Allergan’s depression treatment gets Breakthrough designation

Allergan has been granted a coveted Breakthrough Therapy Designation for a promising new treatment for depression.

The company announced on Friday that the FDA would fast-track the drug, rapastinel (GLYX-13), once it is submitted for review by the company.

This is the first time Allergan has ever gained a Breakthrough Therapy Designation (BTD) for one of its drugs, and arrives as the company prepares to complete its $160 billion merger with Pfizer.

The drug would also be the first treatment for depression approved through the BTD system, which has, until now, been dominated by cancer and rare disease treatments.

Rapastinel was acquired by Allergan when it bought specialist biopharma company Naurex in July last year. The drug is set to enter phase 3 trials later this year, and could help many patients with Major Depressive Disorder.

The standard therapy for depression are the SSRI and SNRI antidepressant classes, but 70% or more of patients are partial or non-responders to these drugs, so new options are urgently needed.

If approved, rapastinel would be given as an adjunct to these treatments, to help increase response rates.

The company points out that the US government-sponsored STAR *D trial showed that only 33% of patients reported remission of their symptoms after monotherapy with an SSRI.

Clinical trial data also suggests rapastinel works rapidly, alleviating depression within just one day, much faster than the older drugs, and is delivered as an intravenous formulation.

The field of depression treatment has had few advances in recent years, with pharma having disinvested in CNS. Allergan’s new drug is one of a new wave of treatments, however, with Johnson & Johnson’s esketamine also in phase 2.

However the risk of failure remains high for novel depression treatments – Alkermes’ drug ALKS-5461 failed in the first two of three key phase 3 studies a few weeks ago.

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