Long-Acting Hemophilia Drug and Buccal Therapy for Opioid Dependence Get FDA Nod
Eloctate: Hemophilia A
The FDA has approved a new prophylactic treatment for hemophilia A.
Eloctate—antihemophilic factor (recombinant) Fc fusion protein—is approved for use in children and adults and is the first hemophilia A treatment designed to be long-lasting, and require less frequent injections.
In a clinical trial of 164 patients, researchers compared treatment with Eloctate to on-demand therapy, demonstrating that Eloctate was effective when treating bleeding episodes, preventing bleeding, and controlling bleeding during surgical procedures.
Reference:
US Food and Drug Administration. FDA approves the first antihemophilic factor, Fc fusion protein for patients with Hemophilia A [press release]. June 6, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm400167.htm. Accessed June 9, 2014.
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Bunavail: Opioid Dependence
Bunavail—a combination of buprenorphine and naloxone—is the first buccal film therapy approved by the FDA for the treatment of opioid dependence.
Unlike other sublingual buprenorphine therapies, Bunavail sticks to the inside of the cheek, allowing patients to talk and swallow normally.
Treatment with Bunavail should go hand-in-hand with psychosocial support and counseling, and lists serious, life-threatening breathing problems as a major concern if the drug is taken intravenously in combination traquilizers or alcohol. It may also cause dizziness, headache, drug withdrawal, lethargy, sweating, constipation, insomnia, and fatigue.
Reference:
Biodelevery Sciences. BioDelivery Sciences receives FDA approval for BUNAVAIL (buprenorphine and naloxone) buccal film for the maintenance treatment of opioid dependence [press release]. June 6, 2014. http://bdsi.investorroom.com/2014-06-06-BioDelivery-Sciences-Receives-FDA-Approval-for-BUNAVAIL-buprenorphine-and-naloxone-Buccal-Film-for-the-Maintenance-Treatment-of-Opioid-Dependence. Accessed June 9, 2014.