While the first line treatment for Parkinson’s is a drug called levodopa, long-term use can cause the medication to wear off before the next scheduled dose. Once the medication fades, patients experience “off” episodes, or periods of low motor function. APL-130277 intends to treat these episodes.
The agency’s Fast Track program is intended to expedite the development and review of new drugs that can treat serious or life-threatening illnesses and address unmet medical needs, according to the FDA’s website.
“We look forward to continuing to work with the FDA to advance APL-130277 through the regulatory process to bring relief to patients suffering with “off” episodes as expeditiously as possible,” said Anthony Giovinazzo, president and CEO of Cynapsus. “Our Phase 3 clinical program is nearing completion and we plan to submit a new drug application to the FDA in the first half of 2017.”
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