- Allergan's antidepressant Raspastinel won a breakthrough therapy designation from the FDA, expanding upon a 2014 fast track classification. Raspastinel is the first Allergan drug to receive a breakthrough designation.
- Acquired last summer in a $560 million deal to buy the biopharma company Naurex, rapastinel is in stage 3 development. It is a ketamine-like NMDA modulator.
- Rapastinel has made headlines in the medical world because of its association with the rapid relief of hard-to-treat depression resulting from off-label treatment with ketamine. Ketamine is an approved anesthetic, but is also a popular club drug for its hallucinogenic effects.
Depression has been a challenging area for R&D, with relatively few new entrants to the category over the last 10 years. Just last month, Alkermes' depression drug ALKS-5461 failed to reach its primary endpoints in two of three phase 3 clinical trials. Drugs such as rapastinel have generated some excitement, bringing a new mode of action to a moribund category.
Rapastinel is part of a handful of pipeline products highlighted by Allergan's CEO, Brent Saunders, as part of the company's overall growth strategy. Along with rapastinel, relamorelin for treatment of gastrointestinal dysfunction, Esmya for treatment of uterine fibroids, and a developmental migraine drug are all projected to be blockbuster drugs.