Sunovion Parkinson’s Drug Heads to FDA, Setting Up Battle With Acorda

Xconomy Boston — 

Another drug that may help alleviate some of the debilitating symptoms of Parkinson’s disease is on its way to an FDA review, setting up a possible commercial battle between two drug developers, Sunovion Pharmaceuticals and Acorda Therapeutics.

Sunovion, of Marlborough, MA, said late Monday that its experimental Parkinson’s drug, APL-130277, succeeded in a 109-patient Phase 3 trial. The drug helped improve the motor function of adult Parkinson’s patients suffering “off” episodes, meaning their medications aren’t working. Sunovion plans to file for FDA approval in the spring.

Sunovion only provided a snapshot of the data; the full details will come at a future medical meeting. What Sunovion did reveal is APL-130277 improved patients’ motor function, as measured by changes of the Unified Parkinson’s Disease Rating Scale (UPDRS)—a well-established measure of patients’ motor symptoms—compared to placebo after 12 weeks of treatment, the study’s main goal. There was a 7.6 percent difference between placebo patients and those on the Sunovion drug. The company also said that, at the 12-week mark, 35 percent of patients were back in an “on” state responding to their other medications within 30 minutes of treatment with APL-130277, compared to 16 percent of placebo patients. Those results were also statistically significant, Sunovion said.

The most common side effects tied to the Sunovion drug were nausea (27.0 percent of patients), drowsiness (14.9 percent), dizziness (14.2 percent), yawning (12.8 percent), and headache (9.2 percent).

About a million people in the U.S. suffer from Parkinson’s, according to the National Parkinson Foundation. The disease causes motor symptoms like tremors, loss of movement, and stiff limbs, and cognitive problems like confusion and memory loss.

There are no drugs that can slow or reverse the course of the disease: levodopa pills, which helps patients manage symptoms and function normally for a longer period of time, have remained the standard of care for the disease since the 1960s. But over time, patients’ responses to levodopa start fluctuating. There are fewer hours per day of “on” time, when the drug is working, and more “off” time, when symptoms re-emerge. To compensate, patients increase their levodopa doses, but that can cause dyskinesia, or uncontrollable, spastic movements. Anywhere from 40 to 60 percent of Parkinson’s patients suffer “off” episodes, according to Sunovion.

The only approved therapy for these patients is the injectable drug apomorphine (Apokyn). But Sunovion’s drug and Acorda’s (NASDAQ: ACOR) rival therapy—both different versions of approved Parkinson’s treatments—could soon be on the market, providing new ways to help combat the fluctuating response problem.

Sunovion’s APL-130277 is a sublingual form of apomorphine. Sunovion acquired the drug when it bought Cynapsus Therapeutics for $624 million in 2016. Acorda’s drug is an inhalable form of levodopa that the company secured through its $525 million buyout of Civitas Therapeutics in 2014.

The full details from Sunovion’s trials—which should shed light on the magnitude of the drug’s benefit—will be telling, as will more understanding of APL-130277’s long-term effects, given some of the issues Parkinson’s patients have with apomorphine. A 10-year observational study published in Internal Medicine Journal in 2017, for instance, showed that patients can have trouble sticking with apomorphine injections over time due to neurological side effects. (Parkinson’s News Today had more on that study here.)

The full Sunovion data will also help handicap a coming commercial battle with Acorda, which could begin this year. Acorda’s drug, known as Inbrija, succeeded in late-stage testing in 2017, but its path to market was delayed when the FDA sent the company a “refusal to file” letter in August. Acorda resubmitted its approval application in December, and expects a response from the agency in February. Inbrija is critical to the future of Acorda, which has suffered several setbacks over the past year and was recently reported to have put itself up for sale.

Here’s more on the Sunovion and Acorda drugs and some of the other emerging therapies for Parkinson’s.