QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today that the United States Patent and Trademark Office (USPTO) issued the Company a new patent, U.S. Patent #7,923,453, which expires in 2029. This patent covers a proprietary dosing algorithm for converting patients from intravenous opioid administration to orally administered MoxDuo IR, thereby more effectively and safely managing acute pain following surgery.
"Patients often respond differently to opioids; this algorithm facilitates the personalised dosing of MoxDuo IR by the clinician, thereby improving efficacy and safety. This is the first of several patent applications filed by the Company to be approved which extend global exclusivity of the MoxDuo Dual Opioid® product line," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "The issued patent describes a clinically derived dosing algorithm to be included in the MoxDuo IR product label to help patients and doctors maintain analgesic control of pain while minimising side effects," Holaday added.
MoxDuo is a patented 3:2 ratio fixed dose combination of morphine and oxycodone that is being developed by QRxPharma in three presentations: oral immediate release (MoxDuo IR), intravenous (MoxDuo IV) and controlled release (MoxDuo CR). These three product candidates are staged to address the $12 billion global market for the treatment of moderate to severe pain. MoxDuo IR targets the acute pain market, a $2.5 billion segment of the $7 billion spent annually on prescription opioids in the U.S.
As the Company's clinical studies consistently demonstrate, MoxDuo effectively treats acute pain while appreciably diminishing the intensity and frequency of moderate to severe opioid-related side effects when compared to frequently prescribed opioids. To date, the Company has successfully conducted twelve clinical trials, including three pivotal Phase 3 studies.
Based on QRxPharma's recent pre-New Drug Application (NDA) meeting with the United States Food and Drug Administration (FDA), the Company believes it is on track to file an NDA in mid-2011 for the use of MoxDuo IR in the management of moderate to severe acute pain.
SOURCE QRxPharma Limited
QRxPharma有限公司(ASX:QRX和OTCQX:QRXPY)今天宣布,美国专利和商标局(USPTO)发行公司一项新的专利,美国专利#7923453,其中2029年到期英寸 这项专利涵盖了从患者静脉给药的专有算法转换为 阿片 政府口服MoxDuo红外光谱,从而更有效地和安全地管理手术后急性疼痛。
“病人往往反应不同 阿片类药物 ,这种算法有利于MoxDuo红外个性化,由临床医生用药,从而提高疗效 和安全性对偶。这是第一次由公司提出的多项专利申请获得批准延长该MoxDuo的全球独家 阿片® 产品线,博士说:“ 约翰霍拉迪,董事总经理兼行政总裁,QRxPharma。 “已发行专利描述了临床用药的算法是派生标签包含在MoxDuo红外产品,以帮助病人和医生保持控制疼痛的镇痛,同时减少副作用,”霍拉迪补充说。
MoxDuo是一种专利比例为3:2的固定剂量复方