Phase III results with Gocovri in Parkinson's disease published in Movement Disorders Clinical Practice.- Adamas Pharmaceuticals.
Adamas Pharmaceuticals announced that subgroup analyses of Parkinson's disease patients taking amantadine immediate release (IR) who were still experiencing dyskinesia and enrolled into EASE LID 2, the long-term, ongoing Phase III open-label study of Gocovri (amantadine) extended release capsules, were published online in Movement Disorders Clinical Practice.
Results from the subgroup analysis showed that the 32 Parkinson's disease patients who were taking amantadine IR at enrollment experienced a 35 percent improvement in motor complications at Week 8, the first post-baseline visit, after transitioning directly to Gocovri, without exacerbating adverse events. The effects were maintained for the 64-week period assessed. The safety and tolerability profile of these patients was consistent with prior controlled studies.
See: "Parkinson's patients with dyskinesia switched from immediate release amantadine to open-label ADS-5102" Stuart H. Isaacson et al, Movement Disorders Clinical Practice online: 5 FEB 2018 03:45AM EST | DOI: 10.1002/mdc3.12595
Comment: Comment: Levodopa is a standard treatment for Parkinsons disease but comes with severe side effects (levodopa induced dyskinesia) that worsen with continued exposure to the drug that is estimated to affect some 15% of Parkinsons patients. Gocovri is a high dose 274 mg amantadine (equivalent to 340 mg amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day when dyskinesia occurs.
Related news and insights
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cevenfacta, intended for the treatment of bleeding episodes.
Calliditas Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorisation for Kinpeygo for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) greater than 1.5 g/gram.