Acorda Therapeutics Announces Agreement with FDA on Special Protocol Assessment for Phase 3 Clinical Trial of Fampridine-SR in Multiple Sclerosis.HAWTHORNE, N.Y. -- Acorda Therapeutics announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) on a Special Protocol Assessment for a pivotal, Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. of Fampridine-SR in multiple sclerosis (MS). A Special Protocol Assessment (SPA) is a process in which the FDA provides evaluation and guidance on clinical trial protocols for Phase 3 studies. "We are delighted to have reached this agreement with the FDA on the design of our pivotal study of Fampridine-SR in MS. We look forward to beginning the study as soon as possible," said Ron Cohen cohen or kohen (Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male. , M.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Acorda Therapeutics. The primary outcome measure for the study will be an improvement in walking as measured by the Timed 25-Foot Walk and the MS Walking Scale-12 (MSWS MSWS Multi-Sensor Warning System MSWS Microsoft Windows Sockets 12). Currently, there are no treatments available that improve walking in MS sufferers, and physicians and patients regularly rate walking as one of the areas of greatest unmet medical need for this condition. Secondary outcome measures for the study include the Lower Extremity Manual Muscle Test (LEMMT), a standardized, 5-point manual assessment of leg strength, as well as the Ashworth score for spasticity and global impressions. MS is characterized by frequent waxing and waning of the patient's walking ability, strength and other neurological functions. The objective of the study will be to show that individuals treated with Fampridine-SR are significantly more likely to have consistent improvements in their walking than those treated with placebo. About Fampridine-SR Fampridine-SR ("4-aminopyridine", "4-AP") is an investigational, sustained-release tablet formulation of 4-aminopyridine. It is being developed in human clinical trials for both MS and spinal cord injury Spinal Cord Injury Definition Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control. Description Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States. (SCI (Scalable Coherent Interface) An IEEE standard for a high-speed bus that uses wire or fiber-optic cable. It can transfer data up to 1GBytes/sec. (hardware) SCI - 1. Scalable Coherent Interface. 2. UART. ). In laboratory studies fampridine has improved impulse conduction in nerve fibers in which the insulating layer, called myelin myelin /my·elin/ (mi´e-lin) the lipid-rich substance of the cell membrane of Schwann cells that coils to form the myelin sheath surrounding the axon of myelinated nerve fibers. , has been damaged. Results from the most recent Phase 2 MS clinical trial showed a positive trend for improvement in average walking speed (as measured by the Timed 25 Foot Walk) and a statistically significant improvement in LEMMT. A post-hoc analysis, using the methods to be applied in the Phase 3 study, showed a significant increase in the number of subjects with consistently improved walking speed in the Fampridine-SR treated group versus the placebo-treated subjects. These data are consistent with from the results of earlier Phase 2 trials. Adverse events, including serious adverse events, seen in these studies were insomnia, paresthesias Paresthesias A prickly, tingling sensation. Mentioned in: Autoimmune Disorders (numbness/tingling), dizziness and nausea, the majority of which were rated as mild to moderate. Seizure was reported in a small number of patients at higher doses than are currently being evaluated. As Fampridine-SR is an investigational drug, safety and efficacy have not been fully determined. About Acorda Therapeutics Acorda Therapeutics, a privately-held biotechnology company, is developing therapies for spinal cord injury (SCI), multiple sclerosis (MS) and related nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency . The Company's marketed products include ZANAFLEX(R)CAPSULES (tizanidine hydrochloride), a short-acting drug indicated for the management of spasticity. For full prescribing information, please go to www.zanaflexcapsules.com. Acorda's lead clinical-stage product is Fampridine-SR, which is being developed for both MS and SCI. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain. |
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