Parkinson's heavy new medicine! FDA approves Kynmobi (apaphonisor) sub-tongue membrane: 15 minutes, OFF event only on-demand sub-tongue therapy

May 22, 2020 /
Biovalley
BIOON/ -- Sunovion Pharma, a U.Ssubsidiary of Sumitomo Pharmaceuticals of Japan, recently announced that the U.SFood and Drug Administration (
FDA) has approved Kynmobi (apomorphine HCl, hydrochloric acid) Apaphinol) sub-sub-sub-membrane agent (sublingual film, APL-130277) for acute intermittent treatment for motor symptom fluctuations (motor fluctuations, or OFF episodes, "OFF" events) in patients with Parkinson's disease (PD)Kynmobi dissolves under the tongue to help PD patients improve their OFF symptoms as neededit's worth mentioning thatKynmobi is the first and only rapid, on-demand treatment for the off-tongue event of Parkinson's disease, which can be used up to five times a dayin phase III, patients treated with Kynmobi had significantly improved motor symptoms within 30 minutes compared to placebosIn the United States, theFDAgranted the APL-130277 fast-track status in August 2016Parkinson's disease (PD) is a chronic neurodegenerative disease in which the cells that produce dopamine are lostIt is projected that the total number of PD patients in the United States will reach 1.2 million by 2030Within 4-6 years of diagnosis, up to 60% of PD patients experience OFF events, regardless of the severity of the diseaseOFF events are the re-emergence or worsening of Parkinson's disease symptoms, some of which are characterized by tremors, stiffness, slow movement, or other symptoms, when oral l-zodoba/carbide bar is controlledThese destructive events can occur when you wake up in the morning and last throughout the dayTHE OFF EVENT IS A COMMON AND CHALLENGING PART OF PARKINSON'S DISEASE, AND THE UNPREDICTABILITY OF ITS ONSET CAN BE EXTREMELY CHALLENGING AND DAMAGING TO THE DAILY LIVES OF PEOPLE WITH PARKINSON'S DISEASE AND THEIR CAREGIVERSSunovion expects Kynmobi to be available in the U.Sby September 2020"
FDAapproval of Kynmobi to expand treatment options for people with Parkinson's disease who experience disensication of OFF events and associated daily activities," said Antony Loebel, President and CEO of SunovionWe are pleased to offer a new treatment to the Parkinson's disease community, which we believe provides patients with a convenient treatment that allows them to quickly improve impaired exercise and better control their motor symptoms when needed"
Kynmobi subcutaneous membrane agent is a new dosage form of apomorphine, a dopamine D2 receptor agonist used as an emergency medicine for OFF events, and is a subcutaneous injection approved in the United StatesKynmobi is a sub-tongue membrane agent that is the first and only rapid, on-demand treatment for the OFF-of-the-mouth treatment of Parkinson's disease, which can be used up to five times a day through a simple sub-tongue doseclinical trials of Phase IIIpublished in The Lancet Neurologyresults showed a significant improvement in motor symptoms in patients with Parkinson's disease during the 12th week of treatment after taking Kynmobi, with an average 7.6-point reduction in the IAAF's Uniform Parkinson's Disease Assessment Scale (MDS-UPDRS) Part III (Exercise Function Check) score compared to placeboWithin 15 minutes of administration, clinical symptoms began to improve In addition, patients treated with Kynmobi had significantly higher rates of complete remission within 30 minutes than those receiving a placebo In the study, Kynmobi was well tolerated, and the most commonly reported adverse events caused by treatment (occurring in more than 5% of patients with higher incidences than placebo) included nausea, oral reactions, drowsiness, and dizziness currently, Kynmobi is being developed as a quick-acting drug for on-demand treatment for all types of "OFF" events, including early morning OFF events, unpredictable OFF events, and endoeffectno off events Kynmobi's sub-tongue administration not only solves the problems caused by subcutaneous injections, but also stabilizes the "OFF" symptoms of Parkinson's disease more quickly and improves safety PD patients (photo: dovehomecare.com) Parkinson's disease treatment, several drugs have been approved in recent years, including :1 Acorda's drug-device Inbrija for intermittent treatment of PD patients with The Cabedoba/Left-spin doba, the first of the 's inhaled levodopa product, hand-held by the patient (2) Concorde's Nourianz (istradefylline tablet), an additional therapy for PD patients who are experiencing an OFF event, has been going on for up to 11 years from the initial rejection of approval by the FDA to final approval (3) Xadago/Equinamide of Weishi/Meiji a new type of selective MAO-B inhibitor for patients with Parkinson's disease who are receiving a drug that contains levodopa to improve the decline in efficacy.) (4) Neurocrine Biosciences Ongentys a new, daily, oral selective catechol-O-methyl transferase (COMT) inhibitor as an adjunct therapy for patients with Parkinson's disease who are experiencing movement fluctuations (OFF events) it's worth mentioning that Ongentys is the first and only approved daily COMT inhibitor that will provide a new treatment to extend the efficacy of Levodoba/Cabidoba January 2018, Fosun Pharmaceuticals granted $18 million from BIAL to acquire exclusive rights to the Chinese market from ONicapone According to domestic research, the prevalence of Parkinson's disease in China's population over 65 years of age is about 17 000 per 100,000, with nearly 100,000 new cases a year (biovalleybioon.com) original source: Sunovion Announces U.S.
FDA app roval of KYNMOBI ™ (apomorphine hydrochloride) Sublingual Film for the Treatment of the Disease's OFF Episodes