The FDA has rejected a Sunovion Pharmaceuticals drug for Parkinson’s disease, delaying the company in its bid to compete with Acorda Therapeutics, which has a similar product that was recently approved for the market.
Sunovion said late Wednesday that the FDA asked for more information to support the application for its drug, APL-130277. But the Marlborough, MA-based company, a subsidiary of Japanese pharmaceutical firm Sumitomo Dainippon Pharma, said that the regulator did not ask for new clinical trials.
The standard-of-care drug for managing the movement symptoms of Parkinson’s disease is levodopa. But after years of use, the drug’s effectiveness can diminish, leading to “off episodes” during which symptoms return. There are older drugs that can treat such episodes. Sunovion’s drug is a reformulation of one of those older medicines, apomorphine, an injectable treatment. Sunovion’s version is delivered via dissolvable film placed beneath the tongue, an approach that’s meant to be a faster-acting alternative to injections.
Sunovion’s drug was expected to compete against Acorda Therapeutics (NASDAQ: ACOR) drug Inbrija. That product, an inhalable formulation of levodopa, won FDA approval in late December. At the J.P. Morgan Healthcare Conference earlier this month, Acorda said it expects to launch Inbrija later in the first quarter of this year. The company did not disclose the drug’s price.
Experts unaffiliated with either Sunovion or Acorda told Xconomy last year that they expect the new Parkinson’s drugs will fill a need, but the key question is how quickly they kick in. In the Phase 3 studies of both Inbrija and APL-130277, the main goal was how patients felt 30 minutes after receiving treatment. Experts wondered whether that quick onset would hold up in real-world use, and whether the benefit to patients will continue as the disease progresses.
Stifel analyst Paul Matteis views the Sunovion drug as a “formidable competitor” to Acorda’s drug. As a sublingual film, the Sunovion drug doesn’t need an inhalation device like Acorda’s product, he wrote in a research note. He added that the Sunovion drug should be more effective for off episodes that occur in the mornings. For now, Sunovion’s regulatory delay leaves Acorda free to negotiate reimbursement with insurance companies without worrying about competition, Matteis said. Following the announcement of Sunovion’s setback, Acorda shares rose more than 3 percent in Thursday morning trading.
Sunovion did not specify what additional information the FDA requested. When the company acquired APL-130277 in 2016 through its buyout of Cynapsus Therapeutics, the drug was in Phase 3 testing and close to reporting preliminary data. But Matteis noted that after closing the acquisition, Sunovion delayed release of those data by more than a year.
“This is surely unusual, and given that the top-line data itself didn’t look controversial, we wonder if there’s anything to study/enrollment changes that has the FDA asking additional questions,” Matteis wrote.