July 2008 Issues

FDA Considers New Rules for Bioequivalence for Locally-Acting GI Drugs -- Quick Pulse

Summary: The FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee discussed – without any vote – bioequivalence (BE) methods for locally-acting drugs that treat gastrointestinal (GI) conditions. The panel considered general issues and did not discuss appropriate methodologies for specific drugs.

More Controversy for Vytorin -- Quick Pulse

Summary: A large European trial of Merck/Schering-Plough’s cholesterol-lowering drug, Vytorin – a combination of 40 mg of Merck’s Zocor (simvastatin) and 10 mg of Schering’s Zetia (ezetimibe) – has shown disappointing results and possibly raised new questions about the drug. The randomized, placebo-controlled SEAS trial of 1,873 patients with mild-to-moderate, asymptomatic aortic stenosis was conducted at 173 sites in Norway , Sweden , Denmark , Finland , Germany , and the U.K.

American Headache Society (AHS)

Summary: GlaxoSmithKline/Pozen’s Treximet is getting off to a strong start, and doctors predicted that 12% of their migraine patients, on average, will be taking it in 6 months. Use may drop when generic sumatriptan is available later this year, but doctors expect use to pick up again because they don’t believe the generic will work as well as Treximet. ♦ Doctors are excited about Merck’s CGRP, telcagepant (MK- 0974), and they predicted that an average of 19% of their migraine patients will be on that 6-12 months after approval, particularly patients who can’t take triptans or have suboptimal response to them. The lack of cardiovascular side effects also is likely to make this a popular drug with primary care doctors. ♦ Allergan’s Botox is used very sparingly off-label in chronic migraine both because reimbursement is extremely difficult but also because many doctors have had disappointing results. ♦ MAP Pharmaceuticals’ inhaled DHE, MAP -0004, is likely to find a niche given its fast onset of action – if it can get FDA approval.