Parkinson's new drug! Sumitomo pharmaceutical's new apomorphine sublingual membrane agent apl-130277 has entered the review in the United States, rapidly treating various off events on demand!

December 27, 2019 / Biovalley bio on / -- Sumitomo Pharma, a US subsidiary of Sumitomo pharmaceutical, recently announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) of apomorphine sublingual film (apl-130277) for the treatment of motor of Parkinson's disease (PD) patients Fluctuations, i.e off exceptions, "off" events) The NDA was resubmitted on November 21 this year, and FDA has designated the target date of PDUFA as May 21, 2020 In August 2016, the FDA granted apl-130277 fast track status It is worth mentioning that at the end of January this year, FDA issued a complete response letter (CRL), refusing to approve apl-130277 At that time, FDA said in CRL that after reviewing the drug's NDA, it was determined that apl-130277 could not be approved with 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 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 Apomorphine (picture source: chemsipider Com) apl-130277 is a new form of apomorphine, which is a dopamine D2 receptor agonist, used as an emergency medicine for off events, and approved in the United States as subcutaneous injection Apl-130277 is a sublingual membrane agent, which is administered by simple sublingual administration At present, apl-130277 is 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 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 The unpredictability of off attack will cause great challenge and damage to the daily life of Parkinson's disease patients and their nurses We look forward to working with FDA for the rest of the review period to bring much-needed off event on-demand treatment options to PD patients " Dr Todd Sherer, chief executive of the Michael J fox Parkinson's Research Foundation (mjff), said: "Parkinson's patients have the same view that the off event will damage their quality of life New treatments may mean that more people are better able to control their symptoms and improve their ability and confidence to control their daily lives " 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 Original source: sunovicon announcements FDA filling acceptance of rejected new drug application for Apollo sublingual film