Merck's New Insomnia Drug No Future Blockbuster

BMI View:  Whilst Merck's Belsomra is a novel addition to a large therapy market in the US, we do not envisage blockbuster sales due to the high use of generic Ambien/Ambien CR. In a time of cost containment, more potential lies in premium-priced areas such as cancer and autoimmune disease.

The FDA has approved Merck's Belsomra (suvorexant) for adults with insomnia who have difficulty falling asleep and/or staying asleep.

Although insomnia is the most highly prevalent (approximately 10-50% of population, depending on how defined and in which country) sleep disorder, only a fraction of patients pursue pharmaceutical treatments. Worldwide, the prescription insomnia therapeutics market is estimated at USD3.3bn. In the US, approximately 70mn prescriptions are written annually for insomnia, representing a USD1.8bn market, with a 5-10% annual growth rate. However, of the 40-70mn American adults who suffer insomnia (of which 25mn are chronic or severe cases), only 20% take prescription sleep aids (source: Somnus Therapeutics).

Merck's New Insomnia Drug No Future Blockbuster

BMI View:  Whilst Merck's Belsomra is a novel addition to a large therapy market in the US, we do not envisage blockbuster sales due to the high use of generic Ambien/Ambien CR. In a time of cost containment, more potential lies in premium-priced areas such as cancer and autoimmune disease.

The FDA has approved Merck's Belsomra (suvorexant) for adults with insomnia who have difficulty falling asleep and/or staying asleep.

Although insomnia is the most highly prevalent (approximately 10-50% of population, depending on how defined and in which country) sleep disorder, only a fraction of patients pursue pharmaceutical treatments. Worldwide, the prescription insomnia therapeutics market is estimated at USD3.3bn. In the US, approximately 70mn prescriptions are written annually for insomnia, representing a USD1.8bn market, with a 5-10% annual growth rate. However, of the 40-70mn American adults who suffer insomnia (of which 25mn are chronic or severe cases), only 20% take prescription sleep aids (source: Somnus Therapeutics).

Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signalling (action) of orexin in the brain.

In July 2013, it was reported that Merck had received a complete response letter (CRL) from the FDA regarding the NDA for Belsomra. In the CRL, the FDA advised Merck that:

  • the efficacy of Belsomra had been established at doses of 10 to 40mg in elderly and non-elderly adult patients;

  • 10mg should be the starting dose for most patients, and needed to be available before Belsomra could be approved;

  • 15 and 20mg doses would be appropriate in patients in whom the 10mg dose is well tolerated but not effective; and

  • for patients taking concomitant moderate CYP3A4 inhibitors, a 5mg dose would be necessary.

In addition, the Agency determined that the safety data did not support the approval of Belsomra 30 and 40mg.

The FDA has now approved Belsomra in four different strengths: 5, 10, 15, and 20mg. According to the Agency, using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.

In the clinical trials to support efficacy, Belsomra was superior to placebo for sleep latency and sleep maintenance as assessed both objectively by polysomnography and subjectively by patient-estimated sleep latency. The recommended dose of Belsomra is 10mg, taken no more than once per night and within 30 minutes of going to bed, with at least seven hours remaining before the planned time of awakening. The total dose should not exceed 20mg once daily.

In clinical studies the most common adverse reaction (reported in 5% or more of patients treated with 15 or 20mg of Belsomra and at least twice the placebo rate) was somnolence ( Belsomra 7%; placebo 3%).

The FDA asked the drug manufacturer, Merck, Sharpe & Dohme, to study next-day driving performance in people who had taken Belsomra. The testing showed impaired driving performance in both male and female participants when the 20mg strength was taken. According to the FDA, patients using the 20mg strength should be cautioned against next-day driving or activities requiring full mental alertness. Patients taking lower doses should also be made aware of the potential for next-day driving impairment, because there is individual variation in sensitivity to the drug.

The FDA has recommended Belsomra be classified by the US Drug Enforcement Administration (DEA) as a scheduled product. Earlier in 2014, the DEA proposed a Schedule IV drug classification under the Controlled Substances Act. The DEA has not yet issued a final decision on the scheduling for Belsomra and therefore product cannot become available before that decision. Belsomra is expected to be available in late 2014 or early 2015.

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