Trevena ($TRVN) secured the FDA's coveted breakthrough therapy designation for its nonopioid pain treatment, giving the company a shot at an early approval as it works through Phase III development.
The treatment, oliceridine, is an intravenous therapy that modulates the body's mu opioid receptors to relieve pain without respiratory and gastrointestinal side effects that limit other agents, according to the company. In a pair of Phase II trials, Trevena's drug beat placebo and measured up to morphine in postsurgery patients, notching significantly lower rates of vomiting, nausea and breathing problems compared with morphine, the company said.
The FDA's breakthrough tag, based on those Phase II results, guarantees Trevena access to top agency officials as it rounds out oliceridine's development, making the company eligible for a shortened agency review once it submits the intravenous therapy.
The FDA has granted 110 breakthrough tags since starting the program in 2012, and oliceridine's designation marks the first time a pain treatment has been brought into the fold.
The news sent Trevena's shares up about 18% on Monday morning.
Trevena, headquartered in King of Prussia, PA, kicked off its Phase III program last month, launching an open-label, 900-patient study to flesh out oliceridine's safety and tolerability. The company said it plans to start a blinded, pivotal trial on the drug in the second quarter of this year, putting it on track to file for FDA approval in the second half of 2017.
Trevena pulled off a $65 million IPO in 2013 to support its pipeline, which includes the Allergan ($AGN)-partnered heart drug TRV027, now in Phase IIb. Behind oliceridine, which was developed as TRV130, Trevena is developing a Phase I oral pain treatment called TRV734 and a preclinical migraine therapy dubbed TRV250.
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