The United States Food and Drug Administration (USFDA) has declined to approve the new first-in-class insomnia drug Suvorexant, the Merck informed. The USFDA was concerned about the safety and starting dose of 10 mg. The pharmacodynamic action of Suvorexant inhibits the action of orexins that play a vital role in wakefulness and sleep.
Suvorexant has been developed by Merck & Co.
After drug safety review, the USFDA has sent a complete response letter to Merck about its decision. According to Merck, the agency was concerned about the patient safety and the dosage was found to be too high. The issue was raised by Peripheral and Central Nervous System Drugs Advisory Committee.
The committee reviewed the proposed dose of 15-30 and 20-40 mg of Suvorexant for elderly and non-elderly patients for induction of sleep and maintenance. However, majority of the members voted against the proposed dose and opted for safe dose of 15 and 20 mg for elderly and non-elderly individuals, respectively. The committee voted against the higher doses due to incidences of next-day somnolence.
In the complete response letter, the USFDA directed that to lower the drug dosage. The existing safety profile of Suvorexant reported the efficacy at doses of 10-40 in elderly and non-elderly insomnia patients, respectively. However, the safety data do not support the approval of doses 30-40 mg. If a patient tolerates 10 mg, the dosage can be increased to 15-20 mg based on clinical response. The initial dose should be reduced to 5 mg in patients who are on concomitant CYP3A4 inhibitors.
In a press release, Dr. Roger Perlmutter, President, Merck Research Laboratories informed that the company will continue to work with the USFDA to get the approval, and Suvorexant will be a new therapeutic option for insomnia.
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