AMSTERDAM, Nov. 25, 2015 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the European Commission (EC) has granted marketing authorization for NUMIENT (Levodopa and Carbidopa), a modified-release oral capsule formulation for the symptomatic treatment of adult patients with Parkinson's disease. The review of this application was conducted under the centralized licensing procedure as a therapeutic innovation, and is applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
"We are pleased that NUMIENT was approved by the European Commission as this not only showcases our R&D capabilities outside the US but is an additional positive review of our quality systems by another regulatory authority," said Fred Wilkinson, President and Chief Executive Officer of Impax. "NUMIENT addresses one of the most significant unmet needs for patients living with this disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled."
"This is our first branded drug approved for commercialization outside the United States and we are in active discussions with potential partners to support the commercialization of NUMIENT in Europe and the rest of the world. We are analyzing the options that will help facilitate the introduction of this product into the global market," concluded Mr. Wilkinson.
The EC decision is based on results from three Phase 3 controlled clinical studies which assessed the safety and efficacy of NUMIENT in patients with early (levodopa-naive) and advanced Parkinson's disease in the U.S. and in Europe. Refer to the "Summary of the Three Phase 3 Controlled Clinical Studies" for additional information.
About Parkinson's disease
Parkinson's disease is a chronic neurodegenerative movement disorder affecting approximately 7 to 10 million people globally . There is currently no known cure for Parkinson's disease.
NUMIENT is indicated (needs updating based on final label) for the symptomatic treatment of adult patients with Parkinson's disease. NUMIENT is not for use in patients with hypersensitivity to the active drug substances or excipients in NUMIENT, narrow-angle glaucoma, phaeochromocytoma, a previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis, or in patients using nonselective monoamine oxidase inhibitors (MAO) inhibitors, which must be discontinued 2 weeks prior to starting to use NUMIENT.
Summary of the Three Phase 3 Controlled Clinical Studies
In APEX-PD, a trial that enrolled and randomized 381 levodopa-naive patients, the study met its primary efficacy endpoint of mean change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) score and UPDRS Part III (motor examination) score for NUMIENT versus placebo at end of study.
In ADVANCE-PD, a trial of 393 randomized patients with advanced Parkinson's disease having "off" time, the results showed treatment with IPX066 (NUMIENT) reduced the percentage of "off" time (36.9% to 23.8%) from baseline versus immediate-release levodopa-carbidopa (36.0% to 29.8%) during waking hours to end of study, representing almost 1.2 hours of additional "off" time improvement. IPX066 (NUMIENT) also increased "on" time without troublesome dyskinesia during waking hours by 1.9 hours compared with an increase of 0.8 hours following treatment with immediate-release levodopa-carbidopa. Less "off" time was primarily related to more "on" time without troublesome dyskinesia.
In ASCEND-PD, a trial of 91 randomized patients with advanced Parkinson's disease having "off" time, compared IPX066 versus levodopa-carbidopa plus entacapone (LCE). Patients entered the study with a baseline "off" time of 36.1% (5.9 hours), and at the end of the randomized IPX066 treatment phase, patients had "off" time of 24.0% (3.8 hours) during waking hours compared to 32.5% (5.2 hours) for LCE (p<0.0001), representing 1.4 hours of additional "off" time improvement.
Summary of the NUMIENT Safety Profile
The most frequently reported adverse reactions in the 978 patients exposed to NUMIENT during the entire clinical program were nausea, occurring in approximately 12% of all patients; dizziness, headache, and dyskinesia, each occurring in approximately 8% of all patients; and insomnia, occurring in approximately 6% of all patients. Serious events of gastrointestinal haemorrhage (uncommon) and of allergic oedema (uncommon) were reported in the clinical studies with NUMIENT.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through its Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platforms and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. For more information, please visit the Company's Web site at: www.impaxlabs.com.
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 Parkinson's Disease Foundation website http://www.pdf.org/en/parkinson_statistics
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