much as 40mg are effective in helping the sleep deprived but may not be safe. Lower doses may work just as well with better safety, but more information may be needed. Currently the lowest strength proposed for marketing is 15mg; if a lower dose was unavailable, the FDA would need to consider if the drug could be marketed safely at all, because they believe that a substantial proportion of the indicated population needs a lower dose. [12]
21/05/2013 08:11:27
Nov 12: Filed and accepted for standard review by the FDA [11].
09/11/2012 08:52:05
Feb 12: Merck report that the two pivotal PIII efficacy trials for suvorexant have been completed and, based on the positive results, they plan to file in the US in 2012 [6].
07/02/2012 21:55:14
Nov 11: US filing planned for 2012-13 [5].
14/11/2011 13:56:55
EU filing planned for 2012 [4].
21/05/2010 17:45:13
Feb 10: Listed as PIII in Merck´s pipeline [1].
03/03/2010 08:09:29
Trial or other data
Mar 14: PIII study (NCT01021813) published in The Lancet Neurology. 322 (62%) of 522 patients randomly assigned to receive suvorexant and 162 (63%) of 259 assigned to receive placebo completed the 1-year phase. Over 1 year, 362 (69%) of 521 patients treated with suvorexant experienced any adverse events compared with 164 (64%) of 258 treated with placebo. Serious adverse events were recorded in 27 patients (5%) who received suvorexant and 17 (7%) who received placebo. The most common adverse event, somnolence, was reported for 69 patients (13%) who received suvorexant and seven (3%) who received placebo. At month 1, suvorexant (517 patients in the efficacy population) showed greater efficacy than placebo (254 in the efficacy population) in improving sTST (38·7 min vs 16·0 min; difference 22·7, 95% CI 16·4 to 29·0; p<0·0001) and sTSO (—18·0 min vs −8·4 min, difference −9·5, −14·6 to −4·5; p=0·0002) [15].
28/03/2014 10:54:56
Nov 12: Study published early online in Neurology (November 28, 2012, doi: 10.1212/WNL.0b013e31827688ee). In the randomized, double-blind, 2-period (4 weeks per period) crossover polysomnography study, 254 patients received suvorexant (10mg, 20 mg, 40mg or 80mg) in one period and placebo (n = 249) in the other. Polysomnography was performed on night 1 and at the end of week 4 of each period. Suvorexant showed significant (p <0.01) dose-related improvements vs placebo on the co-primary end points of sleep efficiency at night 1 and end of week 4. Dose-related effects were also observed for sleep induction (latency to persistent sleep) and maintenance (wake after sleep onset). Suvorexant was generally well tolerated.
30/11/2012 08:33:55
Sept 12: New results from the two-month discontinuation phase of the 12-month PIII RCT showed that, after daily use of a consistent dose of suvorexant for one year, patients who stopped taking the medicine experienced a return of their sleeping difficulties to levels similar to those reported by patients who received placebo over the course of the trial. Patients who continued to receive suvorexant for the additional two months experienced mean improvements in their ability to fall asleep and stay asleep that were consistent with those seen over the first 12 months compared to placebo. Adverse experiences reported in the two-month discontinuation phase were generally consistent with those reported |
