May 2011 Issues

American Psychiatric Association (APA) -- Quick Pulse
Summary: A brief review of the APA meeting, with some perspective on what was hot at the meeting and what was not with respect to newly approved or investigational psychiatric drugs, courtesy of some doctor friends attending the meeting.

American Pain Society (APS)
Summary: Experts predicted that both opioid use and opioid doses will decline due to the FDA’s new opioid REMS. ♦ A number of new medications are in development to treat opioid-induced constipation. Salix’s injectable Relistor is being reserved for very refractory patients. ♦ About 20% of APS members use Suboxone off-label for pain, and use would increase even more if there were an FDA-approved sublingual buprenorphine for pain. ♦ AcelRx’s ARX-01, a sufentanil for postop hospital use, looks very interesting, but ARX-03 for officebased procedures was less impressive. ♦ Industry is still interested in nerve growth factors, and researchers were defending their safety, but the future of the class remains in jeopardy.

FDA Advisory Committee Recommends Approval of 2 HCV Drugs -- and FDA Approves One -- Quick Pulse
Summary: The FDA’s Antiviral Drugs Advisory Committee voted unanimously (18-0) to recommend approval of Merck’s Victrelis (boceprevir) and Vertex Pharmaceuticals’ Incivek (telaprevir) to treat hepatitis C virus (HCV). And on May 13, 2011, the FDA took that advice and approved the first direct-acting antiviral – Victrelis, changing the standard of care for a disease that affects as many as 4 million Americans.