FDA Approves Kynmobi (apomorphine Sublingual Film Agent): Effective In 15 Minutes, The Only Sublingual Therapy On Demand In The OFF Event

- Jun 01, 2020-

Sunovion Pharma, a US subsidiary of Sumitomo Pharmaceuticals, recently announced that the US Food and Drug Administration (FDA) has approved Kynmobi (apomorphine HCl, apomorphine hydrochloride) sublingual film (APL-130277) for Parkinson ’s Acute intermittent treatment of motor fluctuations (OFF episodes, "OFF" events) in patients with disease (PD). Kynmobi dissolves under the tongue and can help PD patients improve their OFF symptoms as needed.


It is worth mentioning that Kynmobi is the first and only sublingual therapy for the rapid and on-demand treatment of Parkinson's disease OFF events. It can be used up to 5 times a day. In the phase III study, Kynmobi-treated patients had significantly improved motor symptoms within 30 minutes compared to placebo. In the United States, the FDA granted APL-130277 Fast Track status in August 2016.


Parkinson's disease (PD) is a chronic neurodegenerative disease in which dopamine-producing cells are lost. It is predicted that by 2030, the total number of PD patients in the United States will reach 1.2 million. Within 4-6 years after diagnosis, no matter what the severity of the disease, up to 60% of PD patients will experience an OFF event.


The OFF event is the reappearance or worsening of Parkinson's disease symptoms when oral levodopa / carbidopa controls the condition, and some of its characteristics include tremor, stiffness, bradykinesia or other symptoms. These devastating events can happen when you wake up in the morning and last throughout the day. The OFF event is a common and challenging part of Parkinson's disease, and the unpredictability of its onset will greatly challenge and destroy the daily life of patients with Parkinson's disease and their caregivers.


Sunovion expects that Kynmobi will be listed in the US in September 2020. Antony Loebel, President and CEO of Sunovion, said: "FDA approval of Kynmobi expands treatment options for patients with Parkinson's disease who experience an OFF event and interruption of related daily activities. We are very pleased to provide a new The treatment plan, we believe this provides a convenient treatment for patients, enabling them to quickly improve impaired exercise and better control their exercise symptoms when needed. "

apomorphine

Kynmobi sublingual film is a new dosage form of apomorphine (apomorphine), which is a dopamine D2 receptor agonist, used as an emergency medicine for the OFF event. The approved dosage form in the United States is subcutaneous injection.


Kynmobi is a sublingual film that is administered by simple sublingual buccal administration. The drug is the first and only sublingual therapy for Parkinson's disease OFF events with rapid, on-demand treatment. It can be used up to 5 times a day Times.


The results of the phase III clinical trial published in "The Lancet Neurology" showed that in the 12th week of treatment, Parkinson's disease patients had significantly improved motor symptoms 30 minutes after taking Kynmobi. Compared with placebo, the International Society of Dyskinesia unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor function test) scores decreased by an average of 7.6 points. Fifteen minutes after administration, the clinical symptoms began to improve. In addition, compared with patients receiving placebo, patients receiving Kynmobi had a significantly higher rate of complete remission within 30 minutes. In the study, Kynmobi was well tolerated, and the most frequently reported treatment-induced adverse events (occurring in more than 5% of patients with a higher incidence than placebo) included nausea, oropharyngeal reactions, drowsiness, and dizziness.


Currently, Kynmobi is being developed as a fast-acting drug for on-demand treatment of all types of "OFF" events, including early morning OFF events, unpredictable OFF events, and end-dose effect OFF events. Kynmobi's sublingual administration method not only solves the various problems caused by subcutaneous injection, but also more quickly stabilizes the "OFF" symptoms of Parkinson's disease, and its safety is greatly improved.


In the treatment of Parkinson's disease, several drugs have been approved for marketing in recent years, including: (1) Acorda's drug-device Inbrija, used for intermittent "OFF" events in PD patients receiving carbidopa / levodopa treatment Sexual therapy, this is the first inhaled levodopa product, which is administered by the patient's own hand. (2) Nourianz (istradefylline tablet) of Concord Kirin, as an add-on therapy for levodopa / carbidopa, is used for PD adult patients undergoing an OFF event. The product was initially rejected by the FDA and finally approved. It has been 11 years before and after. (3) Eisai / Meiji ’s Xadago / Equfina (safinamide), a new type of selective MAO-B inhibitor, used in patients with Parkinson ’s disease who are receiving a drug containing levodopa to improve the efficacy of the treatment Phenomenon (wearing-off phenomenon). (4) Neurogentine Biosciences Ongentys (opicapone), which is a new, once-daily, oral selective catechol-O-methyltransferase (COMT) inhibitor, as levodopa / carbidopa Is an adjunct therapy for patients with Parkinson's disease who are experiencing movement fluctuations (OFF events).


It is worth mentioning that Ongentys is the first and only approved once daily COMT inhibitor that will provide a new treatment regimen to prolong the efficacy of levodopa / carbidopa.


In January 2018, Fosun Pharma obtained the exclusive rights of Ongentys (opicapone) in the Chinese market with a license of 18 million dollars from BIAL. According to domestic research, the overall prevalence of Parkinson's disease in people over 65 years of age in China is about 1700 / 100,000, and the annual number of new cases is nearly 100,000.