The Food and Drug Administration said Tuesday that an experimental psychiatric drug, Saphris, appeared to be safe and effective, reported Reuters.
Reuters reported that a panel of outside psychiatrists would examine and vote on Thursday whether or not the FDA should approve the drug; however, the FDA is not required to make its decision based on the vote.
Schering-Plough Corp. conducted four studies of Saphris, or asenapine, in schizophrenic patients. Two showed positive results, reported the Fort Wayne Journal Gazette, and two other patients diagnosed as bipolar also showed improvement.
If Saphris is approved, Schering-Plough Corp. will enter into the atypical antipsychotic drug competition that is dominated by AstraZeneca’s Seroquel and Eli Lilly’s Zyprexa, which are approved for use in schizophrenic and bipolar patients, reported the Fort Wayne Journal Gazette.
CNNMoney reported that Dr. Thomas Laughren, director of the FDA’s Division of Psychiatry Products, wrote in a memo on June 24 that, “We generally are in agreement that the sponsor has provided adequate support to suggest effectiveness for asenapine for the claimed indications.”
Schering-Plough Corp. said, “Although many antipsychotics are available in the U.S. today, no single medication is effective for all patients with schizophrenia,” reported the Fort Wayne Journal Gazette.
Reuters reported that Schering-Plough Corp. is “expected to be acquired by Merck & Co Inc later this year.”