PHARMACY

J&J receives complete response letter for tapentadol ER

BY Alaric DeArment

RARITAN, N.J. The Food and Drug Administration turned down a regulatory approval application from Johnson & Johnson for a drug to treat chronic pain, J&J said Monday.

 

The drug maker said the FDA issued a complete response letter for tapentadol extended-release tablets. The agency is requesting data concerning the conversion of the extended-release formulation of the drug used in clinical trials to a different formulation designed to increase the drug’s resistance to breaking or crushing by drug abusers. The FDA issues a complete response letter when it needs more data before it can approve a drug.

 

 

“We will engage the FDA in active discussions as quickly as possible so that we can address the requests in the complete response letter,” Johnson & Johnson pharmaceutical research and development therapeutic area head for analgesia Juergen Haeussler said. “We remain fully committed to bringing tapentadol ER to patients experiencing chronic pain as quickly as possible.”

 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Walmart, Humana unveil new Medicare Part D prescription drug offering

BY Mike Troy

BENTONVILLE , Ark. (Oct. 1) Walmart and Humana on Friday unveiled a new Medicare Part D prescription drug offering designed to help both companies gain market share and save money for those enrolled in the program.

Co-branded as the Humana Walmart-Preferred Rx Plan, the program involves a $14.80 monthly premium that is less than half the weighted 2010 national average, generic drug co-payments as low as $2 at Walmart pharmacies and no co-payments for select generics filled via Humana’s RightSource home-delivery service. Humana and Walmart said the program has the potential to save Medicare Part D enrollees as much as $450 annually.

“People are more likely to take the medications prescribed for them when they can afford those medications,” said William Fleming, PharmD, VP Humana Pharmacy Solutions. “And adhering to prescription-drug regimens can enable people to be healthier and prevent future illness. At Humana, we believe that this prevention helps people live healthier lives and achieve lifelong well-being.”

John Agwunobi, M.D., president of Walmart’s Health and Wellness division said Walmart is uniquely qualified to help lower the cost of prescriptions because it is the world’s largest retailer.

“We know every dollar counts, especially when you live on a fixed income. We believe no one should have to choose between buying their groceries or their medications,” Agwunobi said.

He called the program an example of Walmart’s commitment to help people save money so they can live better.

It is also an example of how Walmart can bring more shoppers to its store. There are an estimated 18 million people enrolled in the Medicare Part D program, but that figure is forecast to grow to 26 million by 2015. Open enrollment in the program begins Nov. 15 and continues through the end of the year, and Humana and Walmart are undertaking an extensive media relations and marketing campaign to drive awareness and education. A key element involves kiosks in some 3,000 stores which will occasionally be staffed by Humana representatives.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Teva unveils mid-stage clinical trial results for MS drug

BY Alaric DeArment

JERUSALEM Teva Pharmaceutical Industries and Active Biotech announced promising results from a mid-stage trial of laquinimod, a once-daily oral treatment for relapsing-remitting multiple sclerosis.

The companies released results of a phase-2 extension study of the drug indicating that it was safe for use in patients, but also reduced lesions that are a marker of disease activity by 52%. In addition, the study indicated that the drug reduced relapses of the disease and did not show evidence of suppression of the immune system. Results of the study were published online in the journal Multiple Sclerosis.

The two companies expect to see results of two phase-3 trials of the drug next year. The Food and Drug Administration gave fast-track designation to the drug in February 2009.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?