Newron Pharmaceuticals, a re-search and development company focussed on novel CNS and pain therapies, and its commercial and development partner Zambon S.p.A., an international pharmaceutical company, announced that the NDA for safinamide has been re-submitted to the US FDA. This follows the announcement last week that the CHMP has given a positive opinion on safinamide for Europe.
The submission covers the indications “safinamide as add-on therapy to a stable dose of a single dopamine agonist” in early Parkinson’s disease patients and “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients.
The first submission of safinamide to the US FDA was made in May 2014. On review, the FDA issued a Refusal to File (RTF) letter based on organizational and navigational prob-lems, largely due relating to the hyperlinking of tables, folders and the organization of the table of contents in the submission.
Ravi Anand, Newron’s CMO, stated: “Newron has been in frequent contact with the FDA to propose solutions to the technical issues and obtain their concurrence with the pro-posals. These discussions lead Newron to conclude that the RTF issues have been ad-dressed in this submission.”
PD is the second most common chronic progressive neurodegenerative disorder in the elderly after Alz-heimer’s disease, affecting 1-2% of individuals aged = 65 years worldwide. The prevalence of the PD market is expected to grow in the next years due to the increase in the global population and advancements in healthcare that contribute to an aging population at increased risk for Parkinson’s disease. The diagnosis of PD is mainly based on observational criteria of muscular rigidity, resting tremor, or postural instability in com-bination with bradykinesia. As the disease progresses, symptoms become more severe. Early-stage patients are more easily managed on L-dopa. L-dopa remains as the most effective treatment for PD, and over 75% of the patients with PD receive L-dopa. However, long term treatment with L-dopa leads to seriously debilitat-ing motor fluctuations, i.e. phases of normal functioning (ON-time) and decreased functioning (OFF-time). Furthermore, as a result of the use of high doses of L-dopa with increasing severity of the disease, many patients experience involuntary movements known as L-dopa-Induced Dyskinesia (LID). As the disease pro-gresses, more drugs are used as an add-on to what the patient already takes, and the focus is to treat symp-toms while managing LID and the off-time” effects of L-dopa. Most current therapies target the dopaminergic system that is implicated in the pathogenesis of PD, and most current treatments act by increasing dopamin-ergic transmission that leads to amelioration of motor symptoms. There is a growing belief that targeting non-dopaminergic systems may lead to improvements in PD symptoms such as dyskinesia that are not improved by current dopaminergic therapies.