A drug for the treatment of people suffering effects of Parkinson’s disease that was developed by Mylan Laboratories in Pittsburgh and its subsidiary, Bertek Pharmaceuticals in RTP, apparently is on its way to gaining approval from the FDA.
Mylan and Bertek announced this morning that a new drug application was filed on Dec. 31 for Apomorphin. The drug helps people afflicted with Parkinson’s who suffer what are known as “off” episodes.
“Currently, there are no approved rescue therapies in the United States for Parkinson’s patients who experience sudden and debilitating episodes of total or partial immobility, known as ‘off’ periods,” said Louis DeBone, president and chief operating officer of Mylan in a statement. “This filing is further confirmation of our commitment and ability to develop new drugs that address unmet needs.”
Bertek will market and promote the product when the drug is approved.
According to the Parkinson’s Disease foundation, between 1 million and 1.5 million Americans are afflicted with Parkinson’s. Off those, some 30 percent experience the “off” episodes.