FDA says Schering-Plough drug for schizophrenia and bipolar disorder appears safe, effective

Fed health regulators said experimental psychiatric drug from Schering-Plough appears to be a safe and effective treatment for patients with schizophrenia and bipolar disorder. In briefing documents posted online, FDA's director of psychiatry Thomas Laughren said "we generally are in agreement the sponsor has provided adequate support to suggest effectiveness." He also said the drug appears about as safe as other drugs in the class, known as atypical antipsychotics. He added FDA hasn't reached a final conclusion on the drug. A panel of outside psychiatric experts will vote on whether the FDA should approve Schering's Saphris. The FDA is not required to follow the group's advice, though it usually does. Saphris is one of Schering-Plough's "five stars," a group of key drugs in late-stage development. Kenilworth, NJ.based Schering conducted 4 studies of its drug in schizophrenia patients, 2 of which showed positive results, according to the FDA. 1 agency reviewer state its data in support of short-term efficacy in schizophrenia are not overwhelming, but ultimately show positive results. Schering studied its drug in two trials of bipolar patients, both of which show positive results. Most common side effects with the drug were sleepiness, restlessness, dizziness & weight gain. Antipsychotic drugs are known to cause other serious side effects, including high blood sugar, potential heart problems & tardive dyskinesia, a condition which causes involuntary movement of the neck & face. The FDA already delayed a decision on it once late last year, asking Schering to submit additional info. If approved, Saphris would compete against more established products like AstraZeneca's Seroquel & Eli Lilly's Zyprexa, both of which are already approved for bipolar & schizophrenia & bipolar Those drugs & similar products had combined sales last year of $14.6B, making them top-selling drug class. In its own briefing documents, Schering argued there is a continuing need for add