MEMPHIS, Tenn., Dec. 20 /PRNewswire/ -- Neurorecovery, Inc. (NRI), a biopharmaceutical company focused on treatments for peripheral neuropathies, announces that its request for orphan drug designation of 4-Aminopyridine has been granted for treatment of chronic functional motor and sensory deficits resulting from Guillain-Barre Syndrome (GBS).
Dr. Jay Meythaler, head of NRI's Scientific Advisory Board, commented, "We are encouraged by the orphan drug designation of 4-Aminopyridine for the treatment of chronic functional motor and sensory deficits from Guillain-Barre Syndrome. NRI's mission is to improve the functionality of patients suffering from peripheral neuropathies and this announcement supports our strategic goal to help patients suffering from peripheral neuropathies."
Mr. Edward Labry, Chairman of NRI, commented, "NRI has achieved a major milestone by receiving orphan drug designation as this provides for seven years of market exclusivity in the United States for our proposed indication. Our lead product, Ampydin (IR), is an immediate release, oral administration version of 4-Aminopyridine (4-AP). We intend to develop Ampydin (IR) as a proposed treatment for a number of peripheral neuropathies."
About Neurorecovery Incorporated. NRI is a biopharmaceutical company focused on treatment for peripheral neuropathies. Our lead product, Ampydin (IR), is an immediate release version of 4-Aminopyridine, or 4-AP. 4- Aminopyridine is currently on the FDA's compounding for compassionate use list for treatment of certain neuropathies and for spinal cord injury and MS. NRI is moving into a Phase III clinical trial with the proposed indication of 4- Aminopyridine for the treatment of chronic functional motor and sensory deficits resulting from Guillain-Barre Syndrome. The Phase IIa trial was partially funded by the National Institute of Disability, Rehab and Rehabilitation (NIDRR) and the Phase IIb trial was funded by a grant from the FDA Orphan Drug Office. We are a Delaware Corporation headquartered in Memphis, Tennessee.
Cautionary Note Regarding Forward-Looking Statements. This press release contains forward-looking statements that reflect Neurorecovery's current expectations about its prospects and opportunities, including, without limitation, expectations regarding Ampydin (IR) and its other products. Neurorecovery has tried to identify these forward-looking statements by using words such as "plans," "believes," "expects," "anticipates," "will," "should" or similar expressions, but these words are not the exclusive means for identifying such statements. Neurorecovery cautions that a number of risks, uncertainties, and other important factors could cause Neurorecovery's actual results, performance or achievements to differ materially from those expressed in, or implied by, these forward-looking statements. Drug development and commercialization involves a high degree of risk including the risk of unfavorable results from future studies of Ampydin (IR), delays in obtaining or failure to obtain FDA approval of Ampydin (IR), the inability to obtain additional financing to support Neurorecovery's operations, competition from the biotech and pharmaceutical industries, failure to protect its intellectual property or to defend against the intellectual property claims of others, and other unexpected events.
Neurorecovery undertakes no obligation to update or revise any forward- looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially and investors should not place undue reliance on these statements. Neurorecovery disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Neurorecovery, Inc.CONTACT: Ed Labry of Neurorecovery, Inc., +1-901-537-2992
Web site: http://www.neurorecoveryinc.com/
