Parkinson's new drug! Sumitomo pharmaceutical's new apomorphine sublingual film apl-130277 once again applied for listing in the United States, specializing in off events!

November 23, 2019 / bioun / -- Sumitomo Pharma, a US subsidiary of Sumitomo pharmaceutical, recently announced that it had resubmitted its new drug application (NDA) of apomorphine sublingual film (apl-130277) to the U.S Food and Drug Administration (FDA) for the treatment of motor fluctuations experienced by Parkinson's disease (PD) patients Fluctuations, i.e off exceptions, "off" events) In August 2016, FDA granted apl-130277 fast track status It is worth mentioning that at the end of January this year, apl-130277 was rejected by FDA In the CRL, FDA said that after reviewing the drug's NDA, it determined that apl-130277 could not be approved with the current NDA data, and additional information and analysis were needed, but no new clinical research was needed This resubmitted NDA includes additional analysis of information about the proposed packaging and clinical data Antony loebel, MD, executive vice president and chief medical officer of sunovion and head of global clinical development of Sumitomo Pharmaceutical Group, said: "off is a common and challenging part of Parkinson's disease, and there are few existing treatment options Off events can occur at any time of the day, usually after waking up in the morning and periodically throughout the day, which may disrupt the ability to perform daily activities We look forward to continuing our dialogue with FDA during the review to provide PD patients with the much-needed off event on-demand treatment plan " Apomorphine (picture source: chemsipider Com) PD is a chronic, progressive and neurodegenerative disease The main motor symptoms are tremor, rigidity and motor impairment at rest Non motor symptoms include cognitive and emotional disorders PD is the second most common neurodegenerative disease after Alzheimer's disease (AD) With the aging of the population, the prevalence of PD is gradually increasing At present, levodopa is the "gold standard" for the treatment of PD The proportion of patients taking levodopa is as high as 75% Off events refer to the deterioration or reappearance of PD symptoms under the condition of drug control, including motor and non motor symptoms Off events can occur at any time of the day, usually after waking up in the morning and on a regular basis throughout the day Off event is characterized by tremor, rigidity or slow movement, which will disturb the ability of patients to carry out daily activities and cause heavy burden to patients, families and caregivers It is estimated that up to 40% - 60% of PD patients will have off events, and their frequency and severity will worsen in the course of disease progression These patients urgently need a new drug to effectively control the off event Apl-130277 is a new form of apomorphine, which is a dopamine D2 receptor agonist It is used as an emergency medicine for off events The drug form approved in the United States is subcutaneous injection Apl-130277 is a sublingual film agent It is currently being developed as a quick acting drug for on-demand treatment of all types of "off" events, including off events in the morning, unpredictable off events and off events with end effect The sublingual administration of apl-130277 not only solves various problems caused by subcutaneous injection, but also stabilizes the "off" symptoms of Parkinson's disease more quickly, and greatly improves the safety In terms of Parkinson's treatment, several drugs have been approved for marketing in recent years, including: (1) the medicine equipment inbrija of acorda company is used for intermittent treatment of "off" event of PD patients receiving cabidopa / levodopa treatment This is the first inhaled levodopa product, which is administered by patients themselves (2) As an additional therapy of levodopa / carbidopa, norianz (Istra defylline tablet) of kylin was used in adult PD patients undergoing off events The product was initially rejected by FDA and finally approved, which lasted for 11 years (3) Weicai / Meizhi's xadago / equfina (safinamide), a new type of selective MAO-B inhibitor, is used for Parkinson's disease patients who are being treated with a drug containing levodopa, to improve the phenomenon of declining effect In July this year, the new drug application (NDA) of opicapone, a drug of neurocline Biosciences, was accepted by the FDA of the United States The drug is a new, once a day, oral selective catechol-O-methyltransferase (COMT) inhibitor, which is used as an adjuvant therapy of levodopa / carbidopa for Parkinson's disease patients undergoing off events FDA has designated the prescription drug user fee Act (PDUFA) target date for this NDA as April 26, 2020 If approved, opicapone will provide a new treatment to extend the efficacy of levodopa Neurocrine Biosciences was authorized in 2017 by bial, a Portuguese pharmaceutical company, to acquire the exclusive development and commercialization rights of opicapone in the United States and Canada In the European Union, the drug was approved in June 2016 under the trade name ongentys In January 2018, Fosun Pharmaceutical authorized the exclusive rights of opicapone in the Chinese market for us $18 million from bial, including a down payment of US $3 million and a milestone payment of up to US $15 million According to domestic research, the overall prevalence of Parkinson's disease in the population over 65 years old in China is about 1700 / 100000, and the annual number of new cases is nearly 100000 Source of the original text: Sunrise reserves new drag application for automotive sustainable film