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Axsome’s late-stage study of experimental depression drug misses main trial goal

Photo by Tom Varco

Axsome Therapeutics reported on Monday that its Phase 3 study of its experimental depression drug missed its main trial goal.

It’s drug AXS-05 (dextromethorphan/bupropion) failed to significantly improve depression symptoms compared to bupropion, in patients with treatment-resistant depression (TRD). However this treatment for people with major depressive disorder (MDD) remains on track in its trial phase.

European Commission authorises Janssen’s anti-depressant Spravato

The European Commission has approved Janssen’s nasal spray Spravato (esketamine), which is used to treat major depressive disorder (MDD) that has been treatment resistant (TRD).

Bernardo Soares, Medical Director at Janssen UK, said: “We are proud to be introducing this innovative treatment option, which we hope will help to address a significant unmet need.”

Oral contraceptive use as teenager linked to depression as an adult, study says

Women who have used oral contraceptives as teenagers are more likely to experience depression later in life, according to a study published in The Journal of Child Psychology and Psychiatry.

In a study of 1,236 women from the United States, researchers from the University of British Columbia found that women who had either never used oral contraceptives or had only started using them as an adult were less likely to experience major depressive disorder (MDD) than those women who had used oral contraceptives during adolescence.

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

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.

The Medical Device Directives and The Revision

Pfizer releases new data for Pristiq

Pfizer picture

Pfizer has released positive data for its established antidepressant Pristiq, as it hopes to extend the use of the drug. 

In a long-term study, patients who received 50mg dose of Pristiq (desvenlafaxine) showed a relapse rate of 14%, compared with 30% for those taking a placebo. 

The drug also showed statistically significant reductions in depression symptoms in an eight-week study of peri- and postmenopausal women, compared with a placebo. 

Targacept cuts workforce

The fall-out from pipeline difficulties has led US biopharma company Targacept to make almost half its workforce redundant.

In March the North Carolina-based company announced it would not file depression drug TC-5214, developed with AstraZeneca since 2009, for regulatory review. 

Disappointing Phase III results, where TC-5214 was being tested as an add-on therapy to an antidepressant in patients with major depressive disorder (MDD), sealed the investigational drug’s fate. 

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