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Minerva's insomnia treatment beats Ambien in Phase 2b trial

Published on 25/06/19 at 10:17am

Massachusetts-based firm Minerva Neurosciences has announced that its sleeping pill seltorexant beat both Sanofi’s Ambien (zolpidem) and placebo in treating patients with insomnia.

The Phase 2b trial of 365 patients found that seltorexant showed improvements on the amount of time it took patients with insomnia to get to sleep.

On Night 1 patients taking a placebo showed a 15 minute improvement on the amount of time it took them to get to sleep compared a 23 minute improvement for 5 mg, 43 minutes for 10 mg, and 45 minutes for 20 mg of seltorexant.

Seltorexant also showed improvements in comparison to the standard of care treatment Ambien when it came to a number of different secondary endpoints.  

The Waltham-based biotech is also exploring seltorexant as a treatment for major depressive disorder (MDD).

Professor David Kupfer commented: “observations of seltorexant include a clinically meaningful improvement in symptoms of depression in patients not responding adequately to first line therapies (SSRIs and SNRIs) and a clinically meaningful effect on insomnia in a wide age range of patients.”

 In contrast to Ambien (which works on the GABAA receptor) Minerva’s drug works by blocking the orexin-2 receptor. The orexin system promotes wakefulness.

“Seltorexant is a specific orexin-2 antagonist (SORA) rather than a dual orexin receptor antagonist (DORA) and consequently has a differentiated mechanism of action that may help address numerous psychiatric disorders,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.

“Unlike existing therapies, seltorexant is designed to mimic the natural sleep process by inhibiting the brain mechanisms that promote excessive wakefulness rather than by sedating patients through the activation of the neurotransmitters that promote sleep.”

Professor Thomas Roth, Director of the Sleep Disorders and Research Center at Henry Ford Hospital commented:  “The findings from this study demonstrate that seltorexant significantly improves sleep induction and prolongs sleep duration,”

“The results also demonstrate that seltorexant showed a significantly greater improvement in these sleep parameters compared to zolpidem.”

Louis Goss

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