Following several years of delays tied to manufacturing issues, the FDA has given the OK to Impax Laboratories' ($IPXL) Parkinson's disease drug Rytary. The approval ends a saga for the Hayward, CA-based company that started with a warning letter and led to leadership changes, a securities lawsuit and severe staff cuts.
The drugmaker said today the FDA had approved the extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. It said Rytary is not approved for patients taking nonselective monoamine oxidase inhibitors (MAO) inhibitors.
Impax first ran into issues with a warning letter for its plant in Hayward in 2011, which resulted in a complete response letter for Rytary. The delay led GlaxoSmithKline ($GSK) to rethink its licensing deal with the company, resulting in a financial hit. As Impax worked to overcome its plant problems, its cofounder stepped down as CEO. When new problems arose in Hayward, the drugmaker shifted much of its Rytary production to a plant in Taiwan. It then said it believed it had manufacturing issues resolved and resubmitted the drug for consideration.
Its newfound confidence was premature. In July, the FDA issued a Form 483 for the Taiwan plant including some repeat observations. A week later, Impax announced the FDA had found additional issues with its Hayward facility. In September, the FDA said it was delaying consideration of Rytary. That gave Impax time to work out the issues so it could get the drug approved.
The approval didn't come in time to keep the drugmaker, which has other products, from needing to make some tough financial decisions. It cut 42 jobs, mostly in R&D, in October, after having cut 110 positions the year before that were tied to its plant problems.
- here's the release