Another new Parkinson's disease drug approved by FDA!

Source: the US FDA approved the new drug gocovri (amantadine, amantadine, formerly ads-5102) sustained-release capsule of adamas pharmaceuticals for the treatment of movement disorders in Parkinson's disease patients receiving levodopa treatment recently This is the first and only FDA approved drug for this indication Parkinson's disease is a chronic neurodegenerative disease caused by the loss of dopamine in the brain Patients usually need to use levodopa to replace the lost dopamine The long-term use of the drug can lead to severely impaired mobility This fluctuation can be divided into two stages: in the "on" stage, the patient's motor ability is normal; in the "off" stage, the patient's motor ability is significantly reduced, usually manifested as slow movement, rigidity, walking obstacles, tremor and postural instability According to statistics, about 90% of the patients who use levodopa will have dyskinesia, which is manifested as involuntary, non rhythmic exercise, and unpredictable, which greatly affects the daily life of the patients In the United States alone, there are about 150000-200000 Parkinson's patients suffering from dyskinesia Gocovri is a drug with the potential to improve this situation It contains a high dose (274 mg) of amantadine, which can be taken once a day before going to bed to provide a high level of amantadine for a day to treat movement disorders that occur during the day ▲ the research and development pipeline of adamas pharmaceuticals for the treatment of chronic nervous system diseases (picture source: adamas pharmaceuticals) The approval of gocovri is based on the data of two phase 3 clinical trials In the first trial, patients showed a significant reduction in dyskinesia during 12 weeks of treatment, with a 37% decrease in the unified dyskinesia scale (udysrs) score, compared with a 12% decrease in the placebo group This result was confirmed in the second trial, with a 46% decrease in udysrs scores in patients treated with gocovri, compared with a 16% decrease in the placebo group In addition, in both trials, patients treated with gocovri had a 3.6-4-hour increase in their daily functional time (i.e time without motor impairment), while the placebo group had a 0.8-2.1-hour increase to reach the critical secondary endpoint Common side effects of gocovri include hallucination, dizziness, dry mouth, peripheral edema, constipation, etc "The approval of gocovri is a significant advance in the field of Parkinson's disease treatment, and it is the first FDA approved drug for the treatment of motor disorders in Parkinson's patients," Rajesh, Professor of Neurology at the University of Kansas Medical Center and director of excellence in Parkinson's disease at the University of Kansas Medical system "It's worth noting that gocovri is the first drug that has been shown in clinical trials to reduce both dyskinesia and 'off' phase in Parkinson's patients taking levodopa at the same time," Dr pahwa said The treatment of dyskinesia and off time is still an unmet need in the medical management of Parkinson's disease, and the approval of gocovri is an important step in this direction " ▲ Dr Gregory went, founder, chairman and CEO of Adams pharmaceuticals (photo source: Cantor Fitzgerald) "today's approval is a huge milestone for Adams and Parkinson's disease population," said Gregory, founder, chairman and CEO of Adams pharmaceuticals Dr went said: "gocovri has the potential to help Parkinson's patients suffering from motor disorders and ultimately provide doctors with effective tools to address this long-standing unmet medical needs We would like to thank the doctors, clinical staff, patients and their families who participated in the clinical trials for making it possible for the progress of this group " Adamas pharmaceuticals expects the drug to be available in the fourth quarter of this year and will be fully available in January We congratulate the approval of this new drug, and look forward to its launch to bring treatment options and improve the quality of life for Parkinson's patients suffering from motor disorders.