Pharmaceutical News

Weight loss pill turns into balloon when swallowed

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A new pill that mimics the stomach-restricting nature of weight-loss surgery is helping some patients shed pounds in early trials, British researchers claim.

The pill, called the Obalon balloon, is a capsule containing an a balloon. After a patient swallows the pill, surgeons inflate the balloon inside to make them feel full and eat less.

The device is not permanent though, and needs to be removed after about three months.

“This balloon will act to educate them about portion size and retrain their brain and their mindset a little,” Dr. Sally Norton, a bariatric surgeon at Spire Hospital. Her hospital offers the procedure.

The pill capsule is attached to a tube that can be inflated. Once the capsule hits the stomach, the balloon gets released. A doctor can use an X-ray to find where the balloon is and inflate it with gas through the tube. After, the doctor pulls the tube out through the patient’s mouth, leaving the balloon floating in the stomach.

Up to three balloons are introduced to the stomach over the 12-week period, with placement depending on patient’s fullness and weight loss progress, according to the product website. This fills the stomach, in turn making the patient feel more full.

The device’s makers claim overweight and obese patients can lose up to 20 pounds in three months.

The treatment is not currently approved in the United States by the Food and Drug Administration and is not covered through the U.K.’s National Health Service (NHS). Patients in the U.K. can pay more than $3,300 if they want to get the treatment. A two-balloon procedure may cost about $5,000, according to Van Marsh.image 22

However, experts are not convinced the treatment will be a cure-all for obesity, given the balloons have to be deflated and removed after the 12 weeks are over.

“When they take the balloons out, what happens is the stomach hasn’t shrunk,” Tim Bean, a U.K.-based fitness expert. “So you’re left with the same size stomach, or possibly even bigger than there was beforehand.”

Other medical options for weight loss, like the four types of bariatric surgeries, can be more invasive. Some patients undergo the Lap-band procedure. The band is an adjustable ring that wraps around the upper portion of the stomach. It can be inflated by doctors by placing a small needle into a reservoir and filling it with liquid. The more liquid, the tighter the band gets, which makes the stomach smaller and in turn limits food intake.

Other procedures include the Roux-en-Y gastric bypass, the most common surgery, where a doctor staples a portion of the stomach together to create a smaller pouch to limit how much food a person could eat.

There’s also the less common form of bypass called a biliopancreatic diversion with a duodenal switch, where a large portion of the stomach is removed and the remaining pouch is attached to the last segment of the small intestine.

Another procedure known as a vertical sleeve gastrectomy can also be undertaken. Patients have most of their stomach removed, and the remaining portions are joined by staples, leaving a small tube-shaped stomach that fills up quickly.

Source: cbs news

Biocon to start selling breast cancer drug in India in February

Biocon Ltd said its generic version of Roche’s Herceptin breast cancer treatment would be available to patients in India from the first week of February.

Bangalore-based Biocon jointly developed biosimilar trastuzumab, which received the Indian drug regulator’s marketing approval in November, with U.S.-based Mylan Inc.

About 150,000 people are diagnosed with breast cancer every year in India, of which 25 percent are eligible for treatment with trastuzumab, Biocon said.

Roche decided not to pursue a patent application for its breast cancer drug Herceptin in India, paving the way for generic drugmakers to produce cheaper copies, known as biosimilars because they are not identical to the original drug.

Global sales for Herceptin were valued at about $6.4 billion in 2012, including about $21 million in India, Biocon said.

Source: Reuters

Paracetamol can slow brain development in kids

A new study has found that paracetamol can interfere with the brain development of children, and can even be dangerous for unborn kids.

Researchers at Uppsala University examined paracetamol, one of the most commonly used drugs for pain and fever in children, by giving small doses of it to ten-day-old mice. They later carried out tests on the behavioural habits of the mice in adulthood.

They found that the mice could be hyperactive in adulthood, could display behavioural disturbances, and could have lower memory capability compared to the mice that weren’t given the dose.

Researchers said that the exposure to and presence of paracetamol during a critical period of brain development can induce long-lasting effects on cognitive function and alter the adult response to paracetamol in mice.

They added that parents should be careful in administering the drug.

Researcher Henrik Viberg told the Upsala Nya Tidning newspaper that this shows that there are reasons to restrict the use of paracetamol at the end of pregnancy and to hold back from giving the medicine to infants.

The study was published in the online Toxicological Sciences journal.

Source: Zee news

NYC pharmacy blends Eastern and Western medicine

Positioned on Manhattan’s Decreased East Facet, Stanley’s Pharmacy blends each Japanese and Western medication in an work to aid tackle customers’ requirements.

“I have drugs just like any other pharmacy would,” Stanley said. “And I also have this wellness bar wherever we have our personal blended teas. We have kombucha coming out of the soda fountain in this article, we make our own sodas from scratch and I can customize beverages primarily based on how you sense.”

Stanley’s signature “Drinks and Drugs,” menu presents fixes for typical ailments like a sore throat or PMS – or even a hangover.

It’s this style of personalised care that retains 36-12 months-aged Joe DiNoto coming back. As a runner, DiNoto stated Stanley has assisted him occur up with treatment options that enable him to continue to keep working out with out personal injury.

“I’ve found that my power level is additional dependable all through the day,” DiNoto said. “I also discover that my aches and pains have been lessened due to reduced swelling for the reason that of the tumeric tea. And, I do not know, (I’m) just overall much more satisfied.”

Stanley has been a pharmacist for 15 years and claimed his endeavours to combine pure medication into his 1-of-a-type pharmacy is a thing his consumers take pleasure in.

Monica Stewart, another shopper at Stanley’s Pharmacy, reported she’s now a significant admirer of hoping normal treatments in conjunction with conventional drugs.

“I by no means understood about any of that stuff before…It’s truly opened up my eyes to unique therapeutic methods,” Stewart explained.

Source: USA News

Long-term use of antacids linked to vitamin B12 deficiency

A new study has found that people who took commonly prescribed heartburn and ulcer medications for long term were at higher risk of vitamin B12 deficiency.

Left untreated, vitamin B12 deficiency can increase the risk of dementia, nerve damage, anemia, and other medical complications, some of which may be irreversible. Stomach acid aids in vitamin B12 absorption; suppressing the acids can lead to the health-threatening vitamin deficiency.

Researchers examined the electronic health records (including diagnoses, pharmacy orders, and laboratory results) of 25,956 adult Kaiser Permanente patients diagnosed with vitamin B12 deficiency in Northern California between January 1997 and June 2011, and compared them with 184,199 patients without B12 deficiency during the same time period.

“Patients who took PPI medications for more than two years had a 65 percent increase in their risk of B12 deficiency,” Douglas A. Corley, MD, PhD, a gastroenterologist and research scientist with the Kaiser Permanente Division of Research, said. “Higher doses also were associated with an increased risk, compared with lower doses. Kaiser Permanente’s electronic health records allowed us to look at what happens in the real world for these commonly used medications.”

Among the 25,956 patients who had vitamin B12 deficiency, 12 percent used PPIs for at least two years, compared with 7.2 percent of the control patients. The impact of taking any daily dosage of H2RA medications was less pronounced but also significant: 4.2 percent of patients with B12 deficiency used these medications versus 3.2 percent of control patients.

The study is published in the Journal of the American Medical Association.

Source: health

 

Paracetamol poisoning could be better treated: Study

Patients with paracetamol poisoning could be helped by a new way of delivering an antidote more quickly and with fewer side-effects, researchers say.

Treating patients with the common antidote remedy acetylcysteine over a shorter time period than currently applies leads to fewer side-effects, a trial study found.

Patients are normally given the drug by intravenous drip over a 21-hour period, with a large part of the dose given very quickly.

In a study, patients who received the same dose of acetylcysteine more gradually over a 12-hour period experienced less vomiting and fewer associated reactions.

Their treatment was also less interrupted than those receiving conventional treatment with a 21-hour drip.

Treatment with acetylcysteine often causes vomiting, a drop in blood pressure and other side-effects such as flushing, rashes and difficulty breathing.

Paracetamol is the most common cause of overdose in the UK and every year around 45,000 people are hospitalized for paracetamol poisoning.

The pilot, led by University of Edinburgh scientists, treated more than 200 patients and is the largest trial of its kind for paracetamol poisoning.

The treatment for poisoning was first used and developed by University of Edinburgh doctors in the 1970s.

“Our finding offers a major advance in treating paracetamol poisoning, both in terms of fewer unpleasant side-effects for patients and a shorter hospital stay,” said Nick Bateman, Professor at the University of Edinburgh’s BHF Centre for Cardiovascular Science.

“We need to do more work on a larger population group to find out whether treatment over a shorter time frame is as safe as the current standard,” Bateman said.

The study, published in Lancet, was carried out with the Universities of Newcastle and Aberdeen and funded by the chief scientist office of the Scottish government.

Source: Times of India

J&J, Pharmacyclics leukemia drug effective long term: study

The oral drug, ibrutinib, last month won U.S. approval to treat a rare and aggressive form of non-Hodgkin lymphoma known as mantle cell lymphoma. It is awaiting a Food and Drug Administration decision on treating chronic lymphocytic leukemia (CLL), a slowly progressing form of blood cancer that primarily affects people aged 65 and older.

Some industry analysts had expected the CLL approval to come at the same time as the lymphoma decision. Data from this and other studies being presented at the American Society of Hematology (ASH) meeting in New Orleans could give regulators additional comfort about the medicine’s safety and effectiveness in treating CLL.

“Patients receiving ibrutinib are doing much better than historically what we’re used to seeing with CLL,” Dr John Byrd, a co-leader of the study, said in a telephone interview.

The 148-patient ibrutinib extension study looked at both previously untreated CLL patients and those who had relapsed or stopped responding following prior therapies.

With a median follow-up of more than 27 months of treatment, nearly all of the previously untreated, or treatment-naive, patients and almost three quarters of the relapsed and refractory patients had no evidence of the disease progressing.

REMISSIONS CONTINUE

“With extended follow-up the remissions with ibrutinib appear to be continuing and the safety of this long-term is being maintained,” said Byrd, professor of internal medicine and director of hematology at the Ohio State University Comprehensive Cancer Center in Columbus.

“There has not been an increase of infections or other late-term complications, suggesting that it’s going to be a drug that patients can take for a continued, extended period of time without it being a detriment,” he added.

Researchers had not yet been able to determine median progression-free survival – the point at which the disease begins to worsen for half the patients in a study.

Among previously untreated patients, about 96 percent had not yet experienced disease progression, with just one of 31 patients in that group relapsing so far, researchers said.

Typically you would expect about 50 percent to see disease progression at two years, Byrd explained.

“You don’t even need a statistician to see the difference. The data are better,” he said.

Of the 117 previously treated patients in the extension study, 21 had experienced disease progression and 11 had died within 30 days of receiving their last dose of the drug. That left more than 70 percent whose disease remained in check.

“Ibrutinib is the single most active drug that’s come into the clinic for CLL in terms of the durability of remission induced with it, so it’s going to be a game-changer in CLL,” Byrd predicted.

“A lot of the patients from the initial phase II study have been on drug for two to three years,” he added.

Serious adverse side effects, such as pneumonia, declined after the first year of treatment, researchers said. The incidence of serious side effects was twice as high in patients who had received prior therapies, which may have had more to do with the state of their disease than a reaction to ibrutinib, they said.

“Long term follow-up has only shown a low risk of infection that you would expect to see in this patient population,” said Byrd. “Otherwise the safety has been very favorable relative to other things that have been used in this patient population.”

RBC Capital Markets analyst Michael Yee is forecasting eventual annual worldwide sales of $5 billion for the medicine, now being sold for lymphoma under the brand name Imbruvica.

About 15,000 Americans are diagnosed with CLL each year, according to ASH. While there are effective treatments for the disease, such as chemotherapy combined with Roche’s Rituxan, current therapies can be highly toxic.

Ibrutinib is one of several new medicines for CLL – including one in late stage development from Gilead Sciences Inc – that have fewer toxicities and safety issues and may lead to better quality of life for patients being treated.

“The future will hold combining this with some of the other new targeted therapies that we have coming forward to get complete remissions and hopefully get us onto the path of cure,” Byrd said.

Source: health render

FDA approves new treatment for hepatitis C virus

New drug is part of a revolution in treatment for a virus widespread among Baby Boomers, experts say.A new medication for chronic hepatitis C that can be paired with other drugs to make treatment of the liver-damaging disease faster, easier and more effective got approval from the Food and Drug Administration Friday.

The new medication, called sofosbuvir and made by Gilead Sciences Inc., is part of a “revolution in treatment,” says Douglas Dieterich, a specialist in liver disease at Mt. Sinai Hospital, New York. Dieterich is a consultant to Gilead and other drug companies.

“The upshot is that over the next year to the next 18 months there will be a series of medications approved that will vastly simplify the treatment of hepatitis C for nearly everyone and increase the cure rate beyond 90%,” says David Thomas, a liver specialist at Johns Hopkins Medical Institutions, Baltimore. Thomas says he has no current financial ties to drug makers.

More than 3 million people in the USA are infected with the hepatitis C virus, the nation’s leading cause of liver cancer and liver transplants. Most have no symptoms until their livers start to fail, causing jaundice, fatigue and other problems. Up until now, standard three-drug treatments have taken 24 to 48 weeks and required self-injections of interferon, an immune therapy that can cause difficult-to-tolerate flu-like symptoms and mood swings.

Sofosbuvir, which has the brand name Sovaldi, will be the first treatment that some patients will be able to take for just 12 weeks with just one additional drug and no interferon. The FDA approved the no-interferon combination for patients with two strains of the virus, known as genotypes 2 and 3. For most patients with a more common strain, genotype 1, sofosbuvir is approved to be taken with interferon and an older drug called ribavirin. Some patients still will have to be treated for 24 weeks.

None of the regimens are 100% effective. But in one study, 89% of genotype 1 patients who took the three-drug version were cured in 12 weeks, compared with 75% cured in longer-lasting available regimens, says Ira Jacobson, a liver specialist at Weill Cornell Medical College, New York, who has led drug studies for Gilead.

Sofosbuvir does not add any obvious side effects to those already associated with the drugs it is paired with, he says. So patients taking it with ribavirin may experience fatigue and insomnia and those who also take interferon will have additional side effects, but for a shorter time than in the past, he says

The wholesale cost for a one-month supply of Solvadi will be $28,000, Gilead said in a press release.

Therapies will continue to evolve. For example, some doctors may decide, based on recent studies, to treat some type 1 patients with an interferon-free cocktail of sofosbuvir and another antiviral medication called simeprevir, Dieterich says. FDA approved simeprevir, made by Janssen Therapeutics, in late November, but has not approved the two drugs in combination. Such “off-label” use is legal, but it’s not clear insurers will pay for it, Thomas says.

Doctors also may put off treating some patients with milder illnesses until additional combinations, including one-pill versions, are approved. That’s the “holy grail” of treatment, Jacobson says.

Two medical groups, the American Association for the Study of Liver Disease and the Infectious Diseases Society of America, will publish new online treatment guidelines in January to help doctors make decisions in the rapidly evolving field, Thomas says. He is co-chairing the guideline committee.

Hepatitis C is one of several viruses that can cause liver damage. Vaccines can prevent hepatitis A and B but not C. The virus infects about 16,000 people a year and 75% to 80% develop chronic infections, according to federal Centers for Disease Control and Prevention. Most then develop chronic liver disease and up to 5% die of cancer or cirrhosis.

The virus spreads through blood, most often through shared drug needles, accidental needle sticks and birth. But transmission through sex and through unsanitary tattooing and piercing is possible, CDC says. Because the infection is most common in Baby Boomers, CDC recommends that everyone born between 1945 and 1965 be tested for it

The availability of safe, effective treatment makes it more urgent for people to get tested, Thomas says. Many picked up the virus through youthful drug use, medical mishaps or sex many decades ago and half of those who are infected don’t know it, he says. “We want to find the people who have it so we can give them the treatments and help them.”

More are likely to choose and stick with quicker, easier therapies, Dieterich says. “One of my patients told me that taking interferon was like 48 weeks of having PMS with a cold,” he says. Dieterich says he once had hepatitis C, caused by a needle-stick, and suffered through many months of interferon treatment for it in the late 1990s. It worked, he says, but “it was bad.”

Source: USA today

New data backs promise of long-acting Sanofi insulin

An improved version of Sanofi’s diabetes drug Lantus is better than the old one at controlling blood sugar levels and comes with fewer hypoglycemic events, new late-stage trial data showed on Tuesday.

The treatment is one of several drugs Sanofi is betting on to defend its No.2 spot on the world’s $42 billion diabetes market as its superstar product Lantus, the world’s most prescribed insulin, will lose patent protection by 2015.

The long-acting insulin, known as U300, requires less frequent or lower dosing than Lantus and offers a more consistent insulin release. It is similar to Novo Nordisk’s Tresiba (degludec), also in development.

Analysts expect Sanofi to seek regulatory approval for U300 in the United States and Europe next year and for the drug to reach global sales of $872 million by 2017, according to forecasts compiled by Thomson Reuters Cortellis.

The detailed Phase III results unveiled at the World Diabetes Congress in Melbourne showed U300 was better than Lantus at controlling blood sugar lows at night, a common side effect in diabetics treated with insulin.

The drug also lowered the incidence of hypoglycemic events at any time of the day across the six-month study period.

U300 met its goal in three other Phase III clinical trials, showing similar blood sugar level control as Lantus in patients with type 2 diabetes not previously treated with insulin and uncontrolled on oral medication, as well as in patients with type 1 diabetes already treated with insulin.

Lantus, also known as insulin glargine, was developed in the 1990s and is currently Sanofi’s top-selling drug. It reaped around 5 billion euros ($6.78 billion) in revenue last year.

Sanofi needs a successor for the drug and is also developing a pen-shaped device, known as LixiLan, that combines Lantus with Lyxumia, another diabetes treatment belonging to a class of drugs known as GLP-1 analogues.

The successful launch of both U300 and LixiLan could strengthen Sanofi against rival drugs such as Novo Nordisk’s Tresiba (degludec) and IDegLira, a combination of Tresiba and Victoza.

Novo Nordisk, the global leader in diabetes, faced a setback earlier this year when the U.S. Food and Drug Administration asked for further clinical studies for Tresiba, delaying its potential launch on the world’s largest pharmaceutical market until 2017 at the earliest.

Source: Reuters

Pills of the future: nanoparticles

Researchers design drug-carrying nanoparticles that can be taken orally
Drugs delivered by nanoparticles hold promise for targeted treatment of many diseases, including cancer. However, the particles have to be injected into patients, which has limited their usefulness so far.

Now, researchers from MIT and Brigham and Women’s Hospital (BWH) have developed a new type of nanoparticle that can be delivered orally and absorbed through the digestive tract, allowing patients to simply take a pill instead of receiving injections.

In a paper appearing in the Nov. 27 online edition of Science Translational Medicine, the researchers used the particles to demonstrate oral delivery of insulin in mice, but they say the particles could be used to carry any kind of drug that can be encapsulated in a nanoparticle. The new nanoparticles are coated with antibodies that act as a key to unlock receptors found on the surfaces of cells that line the intestine, allowing the nanoparticles to break through the intestinal walls and enter the bloodstream.

This type of drug delivery could be especially useful in developing new treatments for conditions such as high cholesterol or arthritis. Patients with those diseases would be much more likely to take pills regularly than to make frequent visits to a doctor’s office to receive nanoparticle injections, say the researchers.

“If you were a patient and you had a choice, there’s just no question: Patients would always prefer drugs they can take orally,” says Robert Langer, the David H. Koch Institute Professor at MIT, a member of MIT’s Koch Institute for Integrative Cancer Research, and an author of the Science Translational Medicine paper.

Lead authors of the paper are former MIT grad student Eric Pridgen and former BWH postdoc Frank Alexis, and the senior author is Omid Farokhzad, director of the Laboratory of Nanomedicine and Biomaterials at BWH. Other authors are Timothy Kuo, a gastroenterologist at BWH; Etgar Levy-Nissenbaum, a former BWH postdoc; Rohit Karnik, an MIT associate professor of mechanical engineering; and Richard Blumberg, co-director of BWH’s Biomedical Research Institute.

No more injections

Several types of nanoparticles carrying chemotherapy drugs or short interfering RNA, which can turn off selected genes, are now in clinical trials to treat cancer and other diseases. These particles exploit the fact that tumors and other diseased tissues are surrounded by leaky blood vessels. After the particles are intravenously injected into patients, they seep through those leaky vessels and release their payload at the tumor site.

For nanoparticles to be taken orally, they need to be able to get through the intestinal lining, which is made of a layer of epithelial cells that join together to form impenetrable barriers called tight junctions.

“The key challenge is how to make a nanoparticle get through this barrier of cells. Whenever cells want to form a barrier, they make these attachments from cell to cell, analogous to a brick wall where the bricks are the cells and the mortar is the attachments, and nothing can penetrate that wall,” Farokhzad says.

Researchers have previously tried to break through this wall by temporarily disrupting the tight junctions, allowing drugs through. However, this approach can have unwanted side effects because when the barriers are broken, harmful bacteria can also get through.

To build nanoparticles that can selectively break through the barrier, the researchers took advantage of previous work that revealed how babies absorb antibodies from their mothers’ milk, boosting their own immune defenses. Those antibodies grab onto a cell surface receptor called the FcRN, granting them access through the cells of the intestinal lining into adjacent blood vessels.

The researchers coated their nanoparticles with Fc proteins — the part of the antibody that binds to the FcRN receptor, which is also found in adult intestinal cells. The nanoparticles, made of a biocompatible polymer called PLA-PEG, can carry a large drug payload, such as insulin, in their core.

After the particles are ingested, the Fc proteins grab on to the FcRN in the intestinal lining and gain entry, bringing the entire nanoparticle along with them.

“It illustrates a very general concept where we can use these receptors to traffic nanoparticles that could contain pretty much anything. Any molecule that has difficulty crossing the barrier could be loaded in the nanoparticle and trafficked across,” Karnik says.

The researchers’ discovery of how this type of particle can penetrate cells is a key step to achieving oral nanoparticle delivery, says Edith Mathiowitz, a professor of molecular pharmacology, physiology, and biotechnology at Brown University.

“Before we understand how these particles are being transported, we can’t develop any delivery system,” says Mathiowitz, who was not part of the research team.

Breaking through barriers

In this study, the researchers demonstrated oral delivery of insulin in mice. Nanoparticles coated with Fc proteins reached the bloodstream 11-fold more efficiently than equivalent nanoparticles without the coating. Furthermore, the amount of insulin delivered was large enough to lower the mice’s blood sugar levels.

The researchers now hope to apply the same principles to designing nanoparticles that can cross other barriers, such as the blood-brain barrier, which prevents many drugs from reaching the brain.

“If you can penetrate the mucosa in the intestine, maybe next you can penetrate the mucosa in the lungs, maybe the blood-brain barrier, maybe the placental barrier,” Farokhzad says.

They are also working on optimizing drug release from the nanoparticles in preparation for further animal tests, either with insulin or other drugs.

The research was funded by a Koch-Prostate Cancer Foundation Award in Nanotherapeutics; the National Cancer Institute Center of Cancer Nanotechnology Excellence at MIT-Harvard; a National Heart, Lung, and Blood Institute Program of Excellence in Nanotechnology Award; and the National Institute of Biomedical Imaging and Bioengineering.

Source: MIT News