Amneal Initiates Phase 3 Study for IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa (CD-LD) in Advanced Parkinson's Disease Patients

BRIDGEWATER, N.J., May 7, 2018 /PRNewswire/ -- Amneal(NYSE: AMRX), a specialty pharmaceutical company, today announced it has initiated a Phase 3 trial for IPX203. The IPX203 Phase 3 protocol has been agreed upon with the Food and Drug Administration (FDA) in a Special Protocol Assessment. The study is a randomized, multicenter, double-blind, active-controlled, parallel group study of IPX203 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in patients with advanced Parkinson's disease conducted to assess the safety and efficacy of IPX203. Approximately 500 patients are planned to be enrolled.

"The results from the Phase 2b study provide supporting data on the safety and efficacy profile of the investigational drug, IPX203, and underscore the importance of continuing its evaluation in patients with Parkinson's disease," said Robert Stewart, President and Chief Executive Officer of Amneal. "We are committed to investing in our Specialty business and bringing important products to market for the benefit of patients."

Results from a multiple-dose Phase 2b study in 28 patients with advanced Parkinson's disease, confirmed earlier results from a Phase 2a single dose study that were previously presented at the 2017 American Academy of Neurology meeting as part of the Emerging Science program. Treatment-emergent adverse events (TEAEs) reported in two or more subjects in the multiple-dose study included nausea, dizziness, and dyskinesia.

Dr. Robert Hauser, Professor of Neurology at the University of South Florida and Director of the Parkinson's Disease and Movement Disorders Center said, "As Parkinson's disease progresses, patients develop motor fluctuations such that the improvement from a dose of standard levodopa formulations, called "On", lasts a shorter time and then symptoms return. IPX203 demonstrated a significant increase in the duration of "On" time in both single and multiple dose studies."

The company has also discussed the Chemistry and Manufacturing Controls and clinical development plans for IPX203 with the FDA in end of Phase 2 meetings. The Phase 3 clinical development plan includes a single pivotal double-blind, 13-week efficacy and safety study followed by a nine-month safety extension study. 

About IPX203
IPX203 is an investigational extended-release oral capsule formulation of carbidopa and levodopa, being studied as a potential treatment for the symptoms of advanced Parkinson's disease.  It is designed to have an onset of effect similar to IR CD-LD while providing a longer duration of effect compared to other oral levodopa products available.

About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is an integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has more than 6,500 employees in its operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal is one of the largest and fastest growing generic pharmaceutical manufacturers in the United States, with an expanding portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas. The Company markets a portfolio of branded pharmaceutical products through its Impax Specialty Pharma division focused principally on central nervous system disorders and parasitic infections. For more information, visit www.amneal.com.

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Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events or circumstances.

CONTACT:
Mark Donohue
(215) 558-4526       

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SOURCE Amneal Pharmaceuticals, Inc.