Treatment with Kynmobi (apomorphine hydrochloride), an approved under-the-tongue therapy for “off” episodes in Parkinson’s disease, does not substantially alter heartbeat dynamics at approved doses, according to new clinical trial data. The study, “A Randomized Thorough QT Study of Apomorphine Sublingual Film in Patients With Parkinson’s…

To mark the start of Parkinson’s Awareness Month, the Parkinson’s Foundation has kicked off its #FutureofPD Campaign, an initiative to call attention to the progressive neurodegenerative disorder and highlight what can be done to create a better future for the Parkinson’s disease community. “Parkinson’s disease affects nearly…

Bial has entered into an exclusive agreement to market upon approval in Europe APL-130277 — Sunovion Pharmaceuticals‘ sublingual (under the tongue) film of apomorphine for off episodes in Parkinson’s disease. Under the agreement’s terms, Bial will be responsible for preparing a marketing authorization application for regulatory agencies there — drawing on…

Kynmobi (apomorphine hydrochloride), a sublingual film to treat “off” episodes in people with Parkinson’s disease, is now available in the United States by prescription, its developer Sunovion announced. “People living with Parkinson’s disease can potentially spend hours each day navigating disruptions caused by off episodes, which may…

The U.S. Food and Drug Administration has approved Sunovion’s Kynmobi (apomorphine hydrochloride) as an on-demand sublingual treatment for off episodes, or times when medication wears off, in people with Parkinson’s disease. The medication, formerly known as APL-130277, is an apomorphine film that is placed under-the-tongue (sublingual administration) when…

Sunovion Pharmaceuticals has re-submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), once again seeking the approval of its below-the-tongue formulation of apomorphine — called APL-130277 — for Parkinson’s off periods. The re-submission is a follow-up to the FDA’s “complete response…

The U.S. Food and Drug Administration (FDA) has told Sunovion Pharmaceuticals that it is unable to approve APL-130277 (apomorphine sublingual film) in its present form for the treatment of Parkinson’s disease “off”  periods. Sunovion submitted new drug application for APL-130277 in April 2018. Now the FDA has now…

If the FDA approves Sunovion’s APL-130277 come January, Parkinson’s patients will have a first oral treatment — and a first new treatment in more than a decade — for off episodes, those times of difficulties with movement despite taking treatments that stimulate dopamine receptors, like levodopa. “We think that…

Sunovion Pharmaceuticals’ apomorphine sublingual under-the-tongue film (APL-130277) — now under review for approval —  significantly improved motor fluctuations, or off episodes, in Parkinson’s patients in Phase 3 clinical trial, results show. The double-blind pivotal study, (NCT02469090), evaluated the efficacy and safety of APL-130277 as a fast-acting oral treatment for…

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has launched an educational suite called “Parkinson’s Clinical Trial Companion” to increase patients’ participation in clinical trials. The new resource educates patients and families about the benefits of participating in research, and provides teams conducting clinical trials with high-quality…