FDA Approves add-On drug for Parkinson's Patients with "Off" Episodes

SAN DIEGO --The U.S.   has approved once-daily oral ONGENTYS® (opicapone) as an add-On drug to levodopa/carbidopa for Parkinson's Patients experiencing "Off" Episodes.Opicapone will be available as  25 mg and 50 mg capsules from the company Neurocrine Biosciences. As the disease progresses, patients taking levodopa/carbidopa may begin to experience "off" time between treatment doses, during which an increase in Parkinson's disease motor symptoms such as tremor, slowed movement and difficulty walking occur. ONGENTYS also increases "on" time without troublesome dyskinesia, the time when the motor symptoms of a patient with Parkinson's disease are better controlled. The company plans to launch ONGENTYS later this year.

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"The FDA approval of ONGENTYS represents an important new treatment option for people with Parkinson's disease," said Robert A. Hauser, M.D., Professor of Neurology and Director, University of South Florida Parkinson's Disease and Movement Disorders Center. "As Parkinson's disease progresses, first-line treatments such as levodopa begin to lose effectiveness and the beneficial effects of levodopa begin to wear off more quickly, causing more frequent and often debilitating motor fluctuations in patients. Clinical studies have shown that adding once-daily ONGENTYS to levodopa therapy significantly reduced "off" time, leading to better and more consistent motor symptom control."

Parkinson's disease is the second most common neurodegenerative disorder in the United States after Alzheimer's disease.1 About one million Americans have Parkinson's disease and each year, an estimated 50,000 people in the United States are newly diagnosed with this chronic, progressive and debilitating neurodegenerative disorder.

"The FDA approval of ONGENTYS provides patients living with Parkinson's disease with an important new treatment option to help manage the disruptive and unpredictable motor fluctuations by decreasing "off" episodes and increasing "on" time without troublesome dyskinesia when taking levodopa/carbidopa," said Kevin C. Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "At Neurocrine Biosciences, our mission is to relieve patient suffering and we look forward to working with the Parkinson's disease community to make this new therapy available to patients later this year."

ONGENTYS is an oral, selective catechol-O-methyltransferase (COMT) inhibitor that helps block the COMT enzyme which breaks down levodopa, the gold standard therapy for controlling motor symptoms in patients with Parkinson's disease. ONGENTYS protects levodopa by reducing its breakdown in the blood, making more levodopa available to reach the brain, prolonging its clinical effects, and helping patients achieve motor symptom control.

"Due to the progressive nature of Parkinson's disease, those living with the condition often struggle to control their motor fluctuations, affecting a wide range of functions, including speech, balance, and movement, which adversely impact many aspects of life," said John L. Lehr, President and Chief Executive Officer of the Parkinson's Foundation. "Parkinson's disease community is encouraged by the FDA approval of a new add-on treatment option to help patients further control symptoms, enabling them to better cope with this progressive disease."

The FDA approval of ONGENTYS is supported by data from 38 clinical studies, including two multinational Phase III clinical studies (BIPARK-1 and BIPARK-2), with more than 1,000 Parkinson's disease patients treated with ONGENTYS. In the BIPARK-1 trial, approximately 600 patients with Parkinson's disease and motor fluctuations received one of three doses of ONGENTYS (5 mg, 25 mg or 50 mg), placebo or 200 mg doses of the COMT inhibitor entacapone for 14 or 15 weeks. In the BIPARK-2 trial, approximately 400 patients received one of two doses of ONGENTYS (25 mg or 50 mg) or placebo for 14 or 15 weeks. Both studies included a one-year open-label extension. Data from both trials showed that ONGENTYS 50 mg significantly reduced "off" time from baseline to week 14 or 15 compared to placebo. "On" time without troublesome dyskinesia also increased from baseline to week 14 or 15 compared to placebo.

Pooled safety data from the BIPARK-1 and BIPARK-2 studies indicated that the most common adverse reactions across all patients treated with ONGENTYS (incidence at least 4% and greater than placebo) were dyskinesia, constipation, blood creatine kinase increase, hypotension/syncope, and weight decrease.

In June 2016, BIAL – Portela & CA, S.A. (BIAL) received approval from the European Commission for ONGENTYS as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. BIAL currently markets ONGENTYS in Germany, United Kingdom, Spain, Portugal and Italy. Neurocrine Biosciences in-licensed opicapone from BIAL in 2017 and has exclusive development and commercialization rights in the U.S. and Canada.