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Transdermal Patch Shows Promise in Parkinson’s Disease
Positive results have been reported from a recently completed bioavailability study that examined the delivery of TPU-002RA (Teikoku Pharma USA), a 7-day rasagiline patch, for patients with Parkinson’s disease (PD). The study was part of the FDA’s recommended program for a new drug application (NDA) for TPU-002RA and will be a critical component of the product’s NDA.
TPU-002RA is a transdermal patch system that contains the same active drug component in Azilect (Teva Pharmaceuticals), the only currently marketed form of rasagiline. In the new study, one patch of rasagiline applied for 7 days achieved a higher systemic exposure than that of rasagiline 1-mg tablets (Azilect) administered orally once daily for 7 days. In addition, the patch produced more-consistent blood levels of rasagiline throughout the 7-day period without significant peaks, which were seen with the oral product.
PD is the second most common neurodegenerative disease after Alzheimer’s disease, affecting between 1.0 million and 1.5 million Americans. The primary symptoms of the disorder (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.
In addition to the need to develop a therapy to slow the progression of PD, several other important needs exist:
- Alternative delivery systems to counter difficulty swallowing
- New drugs to delay the onset of dementia with fewer adverse effects
- A “cure” that repairs and/or reverses the neural damage
- Simplification of complex medical regimens
Source: PR Newswire; December 2, 2014.