Levodopa hydrate

At long last, the FDA approved Supernus Pharmaceuticals’ Parkinson’s disease treatment, which will be marketed as Onapgo. Onapgo is now approved to treat motor fluctuations in adults with advanced Parkinson’s disease. Previously known as SPN-830, the therapy is administered using a pump that continuously delivers apomorphine, a drug used to treat what’s known as “off” episodes in Parkinson’s disease. That’s when Parkinson’s symptoms, like stiffness or tremors, affect patients between doses of medication such as levodopa. In a Phase 3 study, Onapgo reduced the amount of daily “off” time by 2.6 hours compared to 0.9 hours with placebo at 12 weeks. Supernus said Onapgo will be available in the US in the second quarter of this year. Supernus declined to disclose the price for Onapgo, saying it isn’t commenting on pricing before the product is commercially available. Its stock $SUPN was up about 5% on Tuesday morning. The regulator’s approval occurred less than a year after it rejected the treatment for the second time in April. At that time, the FDA said it needed additional information or review time for two items: product quality, and the “master file” for the device part. In 2022, the agency also rejected the drug-device, and in 2020, the FDA refused to review Supernus’ application for SPN-830. Other companies have or are developing similar therapies. AbbVie in October received FDA approval for Vyalev, which is a continuous infusion used to treat Parkinson’s. And Mitsubishi Tanabe Pharma is working to resubmit an application to the FDA for its continuous infusion pump ND0612 after it was rejected. Supernus acquired the program in 2020 as part of its $300 million purchase of US WorldMeds’ CNS portfolio. Supernus is also the maker of the ADHD drug Qelbree, among other drugs for psychiatric and neurologic conditions. Editor’s note: This story was updated with Supernus’ comment on pricing.

A new Supernus Pharmaceuticals medical device that continuously administers an old Parkinson’s disease drug is now FDA approved, giving patients another way to manage the motor control symptoms that return when the effects of standard treatment for the neurological disease wanes. The drug/device combination product, known in development as SPN-830, will be commercialized under the brand name Onapgo. Supernus said Tuesday it plans to launch Onapgo in the second quarter of this year. In an email, the Rockville, Maryland-based company, which specializes in treatments for central nervous system diseases, said it cannot comment on pricing of products before they become commercially available. The backbone of Parkinson’s treatment is levodopa, a compound that is converted to dopamine in the brain to boost levels of this brain chemical that patients lack. The periods when this medication works are called “on” times. But Parkinson’s patients also experience “off” times when levodopa therapy wears off and motor symptoms return. One treatment option for these off periods is a different drug, apomorphine. presented by sponsored content, Artificial Intelligence What Keeps Healthcare CIOs Up at Night: Balancing Technology Investments with Consumer Expectations When it comes to managing inbound phone calls, underperformance has devastating cost implications. By Stephanie Baum Apomorphine mimics dopamine, binding to receptors responsible for motor control. An FDA-approved injectable version of this drug has been available for more than 20 years for treating the off episodes of Parkinson’s. In 2020, Sunovion Pharmaceuticals’ sublingual film formulation of apomorphine received FDA approval for intermittent treatment of the off episodes of Parkinson’s. Supernus already has a presence in Parkinson’s. Its second-largest product by revenue is Gocovri, a capsule that treats dyskinesia and off time in Parkinson’s patients. The company also already markets apomorphine, dosed as needed via an injection pen product branded as Apokyn. But motor symptoms of Parkinson’s worsen as the disease progresses and off periods can happen at any time. Continuous infusion of apomorphine offers an additional way to manage these unpredictable off times. Supernus sources Apokyn from Britannia Pharmaceuticals, a subsidiary of German company Stada Arzneimittel. Britannia markets both injectable and continuous infusion apomorphine products in Europe. A license and supply agreement with Britannia grants Supernus the right to use and market injectable apomorphine in the U.S. The 2016 pact also covers the joint development of other apomorphine products, including drug administered as a continuous infusion. Supernus must pay Britannia royalties on net sales for products covered by the agreement. Britannia retains rights to its drug outside of the U.S. Onapgo, a device secured to the body by an elastic band worn around the waist, has had a rocky regulatory journey leading up to its FDA nod. Supernus applications seeking regulatory approval were turned back by the FDA in 2022 and again last April, as the agency asked for more information about various aspects of the drug/device combination product candidate. Last August, the FDA accepted Supernus’s resubmitted application and set a Feb. 1 target date for a regulatory decision. presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical The long-awaited FDA approval is based on the results of a placebo-controlled Phase 3 test that evaluated Onapgo for 12 weeks. Results showed that patients who received the Supernus treatment experienced a 2.6-hour reduction in daily off time compared to 0.9 hours for those who received a placebo. Patients who received the Supernus treatment also experienced an increase in on time for their Parkinson’s medications — 2.8 hours for the Onapgo arm compared to 1.1 hours for the placebo group. The most common adverse events reported in the study included infusion-site reactions, nausea, sleepiness, dyskinesia, headache, and insomnia. In Supernus’s announcement of the product approval, Dr. Rajesh Pahwa noted the 30-year history of continuous subcutaneous apomorphine infusions in Europe. Pahwa, a professor of neurology at the University of Kansas School of Medicine, director of the Movement Disorder Program at The University of Kansas Health System, and an investigator for Onapgo’s clinical trial, pointed to the significant reduction in off time and increase in on time for patients treated with the Supernus product. “Today’s approval of Onapgo means patients in the U.S. who are not responding well to their current treatment regimen, including levodopa, will now have the option of using a small and lightweight wearable device to deliver a continuous infusion without the need for an invasive surgical procedure,” Pahwa said. Photo by Supernus Pharmaceuticals