SAN JOSE, Calif., Dec. 2, 2014 /PRNewswire/ -- Teikoku Pharma USA announced positive results of a recently completed bioavailability (BA) study examining the delivery of TPU-002RA, a 7-day rasagiline patch, for Parkinson's disease. This study was part of the U.S. Food and Drug Administration (FDA) recommended program for a 505(b)(2) New Drug Application (NDA) for TPU-002RA and will be a critical component of this product's NDA.
The study confirmed that one patch of rasagiline applied for 7 days achieved a higher systemic exposure than that of AZILECT® (rasagiline) 1mg tablets administered orally once daily for 7 days. Additionally, the patch produced more consistent blood levels of rasagiline throughout the 7 day period, without any significant peaks as seen with the oral product.
Paul Mori, Executive Vice President and COO said, "We are pleased to have demonstrated the ability of our unique transdermal drug delivery technology to provide systemic drug exposure equivalent or greater than the oral product at its therapeutically effective dose. The patch offers the potential for improved medication adherence and reduction of caregiver workload." He continued, "The outcome of this study not only satisfies the FDA's request, but also enhances the probability of success for a patient-friendly rasagiline product."
About the Parkinson's Disease Market
Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease. There are between 1 and 1.5 million Americans living with Parkinson's disease.1 Worldwide patient population is estimated to 4 million and projected to grow to over 9 million cases.2,3 The main symptoms (stiffness, tremors, and slowed movements and gait) are caused by a loss of dopamine production by the neurons that are involved in controlling movement and coordination. 4,5 Overall, world revenue for drugs treating PD will reach $3,426M in 2016.5,6 There are 8 major anti-Parkinson drugs in U.S. market with MIRAPEX®, Carbidopa/levodopa, and REQUIP®. AZILECT® had 2013 sales of $240M in the US and $248M for Europe and Asia market, and is still enjoying sales growth of 19.4% growth in the US.7,8
Besides the foremost need to develop a therapy to slow Parkinson's disease progression, several other important needs exist:
- Alternative delivery systems to counter difficulty swallowing;
- New less side-effect laden drugs for the delay of onset of dementia;
- Cure that repairs and/or reverses the damage; and
- Simplification of complex medical regimens.
About TPU-002RA
TPU-002RA is being developed for the treatment of Parkinson's disease. This product uses Teikoku's unique transdermal patch system and contains the same active drug component in AZILECT®, the only currently marketed form of rasagiline. Teikoku believes that our TPU-002RA offers potential advantages over AZILECT® oral and could seize a meaningful share of this rapidly growing market.
About Teikoku Pharma USA
Teikoku Pharma USA Inc.("TPU"), a wholly owned subsidiary of Teikoku Seiyaku Co., Ltd. of Japan, is an international specialty pharmaceutical company that develops and manufactures pharmaceutical products based on our delivery platform technologies.
TPU is the NDA holder of LIDODERM® (Lidocaine 5% Patch) for post herpetic neuralgia (PHN), and Lidoderm is currently distributed by Endo Pharmaceuticals in the US, Grünenthal GmbH mainly in Europe, South America and Oceania, and other distributers in Asia.
Teikoku's internal therapeutic focus is addressing unmet medical needs in the pain management, central nervous system, and oncology categories.
For more information please contact: Francisco Bejar at fbejar@teikokuusa.com
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