Lundbeck, Takeda report more Phase III MDD data

H. Lundbeck A/S (CSE:LUN) and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) presented additional data on Monday showing that some doses of Brintellix vortioxetine significantly improved depression rating scores while other doses did not in four Phase III trials for the acute treatment of major depressive disorder (MDD). An NDA for the serotonin modulator and stimulator is under FDA review to treat MDD, with an Oct. 2 PDUFA date. An MAA for the product is also under review for the indication in Europe. Lundbeck said both the NDA and MAA include a 5-20 mg Brintellix dose range. Data from all of the trials are included in the applications.

In Study 315, once-daily 20 mg Brintellix met the primary endpoint of reducing Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to week eight vs. placebo (p=0.023), while a once-daily 15 mg dose missed the endpoint (p-value not disclosed). In Study 13267A, once-daily 15 and 20 mg doses of Brintellix each met the primary endpoint (p<0.0001 for both), while in Study 316 once-daily 20 mg Brintellix met (p=0.002) but once-daily 10 mg missed the primary endpoint (p=0.058). In Study 317, once-daily 10 and 15 mg doses of Brintellix each missed the primary endpoint (p-values not disclosed). The double-blind trials enrolled 2,181 patients aged 18-75. Data from all the trials were presented at the American Psychiatric Association meeting in San Francisco. ...