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Merck's Insomnia Drug Belsomra Approved by the FDA

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Merck (MRK) announced that the FDA has approved its insomnia drug, Belsomra (suvorexant). Belsomra is a highly selective antagonist for orexin receptors indicated for adults with insomnia who have difficulty falling asleep and/or staying asleep.

The FDA has approved Belsomra in four different strengths (5 mg, 10 mg, 15 mg and 20 mg). The FDA noted that Belsomra should be taken no more than once a night within 30 minutes of going to bed with more than 7 hours remaining before the planned time of awakening. The total dose of Belsomra should not exceed 20 mg once daily while the recommended dose is 10 mg.

The Drug Enforcement Administration (:DEA) will assign the schedule for the drug before it is launched. Earlier this year, the DEA had proposed Schedule IV of the Controlled Substances Act for Belsomra. However, the final decision is pending following which the drug will be launched. Thus, Belsomra is expected to be available in late 2014 or early 2015.

We remind investors that the regulatory path for Belsomra was not smooth. The FDA had issued a complete response letter (CRL) for the drug last year.  

Our take

We are pleased with the approval of Merck’s insomnia drug. We note that the approval marks the first orexin receptor antagonist for treating insomnia. However, the insomnia market is highly competitive and genericized especially given the presence of generic versions of Sanofi’s (SNY) Ambien.

Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Allergan (AGN) and AstraZeneca (AZN). While Allergan sports a Zacks Rank #1 (Strong Buy), AstraZeneca is a Zacks Ranked #2 (Buy) stock.

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