Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the United States Patent and Trademark Office (USPTO) has allowed U.S. Patent Application No. 11/010,828 entitled "Sustained Release Aminopyridine Composition." The claims of the patent application relate to methods to improve walking in patients with multiple sclerosis (MS) by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. The patent that issues from this application, which will be eligible for listing in the U.S. Food and Drug Administration Orange Book, is set to expire in early February 2026, based on the USPTO's calculated patent term adjustment of 413 days, which the Company is currently evaluating.
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is marketed in the United States by Acorda Therapeutics, Inc. It is approved in the Unites States as a treatment to improve walking in people with MS. This was demonstrated by an increase in walking speed.
Important Safety Information
AMPYRA can cause seizures; the risk of seizures increases with increasing AMPYRA doses. AMPYRA is contraindicated in patients with a prior history of seizure. Discontinue AMPYRA use if seizure occurs.
AMPYRA is contraindicated in patients with moderate or severe renal impairment (CrCl≤50 mL/min); the risk of seizures in patients with mild renal impairment (CrCl 51-80 mL/min) is unknown, but AMPYRA plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; estimated CrCl should be known before initiating treatment with AMPYRA.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.
Urinary tract infections were reported more frequently as adverse reactions in patients receiving AMPYRA 10 mg twice daily compared to placebo.
The most common adverse events (incidence ≥2% and at a rate greater than the placebo rate) for AMPYRA in MS patients were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosisrelapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.
Source: Acorda Therapeutics
阿索尔达治疗公司（Nasdaq：ACOR），题为今天宣布，美国专利和商标局（USPTO）已允许美国专利申请号11/010 828，“缓释氨基组成。” 专利申请的权利要求涉及到的方法，提高患者的步行 多发性硬化症 （MS）的每天10毫克的管理缓释4 -氨基吡啶（dalfampridine）两次。 当前专利书的问题，从这个应用程序，当局会药物有资格上市，在美国食品和奥兰治，是集届满二月初2026年，根据美国专利商标局的计算专利期限调整413天，本公司评价。
AMPYRA ® （dalfampridine）缓释片，10毫克的人销售与MS在美国由阿索尔达治疗的，公司是国家批准的国家为美国走提高待遇。 这体现在增加的速度行走。
重要安全信息
AMPYRA可导致癫痫发作，剂量癫痫的风险增加AMPYRA随。 AMPYRA患者是禁忌的历史事前