Two drugs with local ties receive FDA approval

Posted by John Murawski on June 9, 2014 

Federal drug safety officials on Friday approved two medications with ties to the Triangle. The two drugs represent years of research and will be commercially released this year.

The U.S. Food and Drug Administration approved BioDelivery Sciences International’s treatment for addiction to opioids such as OxyContin, morphine and heroin. The Raleigh company’s drug, Bunavail, is administered inside the cheek instead of being held under the tongue like the current leading treatment.

The FDA also approved Biogen Idec’s drug for Hemophilia A that requires fewer infusions than the current leading medication. Biogen Idec would produce the drug, Eloctate, at its facilities in Cambridge, Mass., and in the Triangle, where it employs 1,100 in Morrisville and 100 in Durham.

BioDelivery’s opioid addiction treatment takes an increasingly important path in drug development, in which the innovation has to do with the way the drug is administered. By attaching Bunavail to the cheek, opioid addicts can talk, swallow and perform normal life functions while the drug is being absorbed into their bodies.

The company said that about 40 percent of patients experienced constipation from the leading treatment, Suboxone, before they switched to Bunavail.

Three months ago BioDelivery signed a deal with Durham-based Quintiles in which Quintiles will launch Bunavail, including recruiting and training a field sales force to market the drug to health care providers.

The main goal of treating opioid addiction is to reduce dependance on illegal drugs, and thereby to reduce criminal behavior, BioDelivery said in a statement.

Biogen Idec plans to make its Hemophilia drug commercially available next month. Eloctate is taken once every three to five days, instead of every other day.

Hemophilia A is the more common form of the condition in which blood doesn’t clot properly, affecting about 142,000 people worldwide. It causes swelling, pain and sometimes leads to death.

Eloctate was tested on 165 male adolescents and adult men with severe Hemophilia A. The test reduced bleeding incidents and only two patients had to withdraw for side effects (rash and joint pain).

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