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major depressive disorder

Sage Therapeutics' depression drug falls short at Phase 3

Sage Therapeutics has announced that its candidate SAGE-217 flopped in Phase 3 trials investigating its efficacy in symptom reduction for major depressive disorder (MDD) in adult patients.

The drug failed to meet its primary endpoint of significant reduction from baseline in MDD symptoms, as measured on the 17-item Hamilton Rating Scale for Depression (HAM-D) after 15 days of treatment.

FDA fast-tracks psilocybin treatment for major depressive disorder

The FDA has granted a Breakthrough Therapy designation to the Usona Institute for its trial use of psilocybin in the treatment of major depressive disorder (MDD), with the view of accelerating trials testing its efficacy.

Non-profit research organisation The Usona Institue is examining the antidepressant properties of a single psilocybin dose in treating patients with major depressive disorder.

Lundbeck and Takeda's depression drug approved in Japan

Takeda and Lundbeck have announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has chosen to authorise their drug Trintellix (vortioxetine) for the treatment of major depressive disorder, described in the companies’ press release as “depression and depressed state”.

This marks the 84th national approval for the drug, which is already marketed in the US, Europe, China, Canada, Australia, South Africa, Mexico, Argentina, and South Korea to name a few.

Janssen's argues for the cost-effectiveness of Spravato in treatment-resistant depression

Janssen has unveiled a new cost-effectiveness analysis for its recently FDA-approved nasal spray Spravato (esketamine) in the treatment of treatment-resistant depression (TRD) at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting (ISPOR 2019).

The company argued that Spravato, in combination with an oral antidepressant, is a cost-effective alternative to the combination of an oral antidepressant and placebo in the treatment of TRD, defined as those patients who have not responded to two or more oral antidepressants within the same depressive episod

Allergan's depression drug rapastinel fails to outperform placebo at Phase 3

As Janssen celebrated the FDA approval of the first novel therapy for depression in three decades with Spravato, Allergan released new, but unfortunately disappointing Phase 3 data for its own therapy rapastinel, confirming that it failed to outperform placebo in the treatment of major depressive disorder (MDD).

In the three acute trials sought to compare the efficacy of rapastinel in combination with antidepressant therapy (ADT) compared to p

FDA knocks back Alkermes' opioid-based depression therapy over lack of evidence

Alkermes experimental opioid-based depression therapy ALKS 5461 has been rejected by the FDA, it has emerged, in the adjunctive treatment of major depressive disorder (MDD).

The US agency confirmed the decision in a complete response letter, refusing to approve the drug in its current form. Alkermes has been requested to provide additional data to support its efficacy, and the company, in turn, confirmed that it would meet with the FDA to discuss how these concerns could be rectified.

Alkermes sent reeling as FDA refuses review of depression treatment

Alkermes shares were knocked down to their lowest level since October 2016 after it was revealed that the FDA had refused to review its major depressive disorder (MDD) treatment ALKS 5461 due to concerns the company provided insufficient evidence to adequately determine its efficacy.

Alkermes confirmed that it had received a ‘Refusal to file’ letter from the US regulator, with Chief Executive Officer Richard Pops noting in a conference call that the company was, “based on our previous interactions with the agency, surprised” at the FDA’s decision.

Phase III depression trial success for Alkermes

Biopharma company Alkermes has announced the success of its ALKS 5461 treatment in a Phase III study for the treatment of major depressive disorder (MDD), which met its primary endpoint and sent shares rocketing as much as 52%.

The success follows the company’s previous failure in two Phase III trials of the drug in January.

FDA approves Lundbeck and Otsuka’s Rexulti for depression

Rexulti (brexpiprazole)

Lundbeck and Otsuka have gained a yes vote from the FDA for their jointly-marketed antidepressant, Rexulti.

The US regulator approved the drug as an adjunctive therapy for the treatment of major depressive disorder (MDD) in adults with schizophrenia. As a result of the decision, the companies say Rexulti (brexpiprazole) is expected to become available in the US in early August 2015. 

Forest depression candidate struggles against placebo

An investigational antipsychotic drug being developed by Forest Laboratories and Budapest-based Gedeon Richter has failed to prove itself in phase II trials.

Cariprazine is being studied as a once-daily adjunctive therapy in major depressive disorder (MDD) in an eight-week study of patients who haven’t responded to at least two antidepressant therapies (ADT).

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