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