Core Viewpoint - Scienture Holdings, Inc. has entered into a definitive agreement with Summit Biosciences for the exclusive U.S. rights to launch REZENOPY, a naloxone HCl nasal spray, aimed at addressing the opioid overdose crisis [1][4]. Company Overview - Scienture Holdings, Inc. operates through its subsidiaries, focusing on developing and distributing novel specialty pharmaceutical products to meet unmet market needs [11]. - Scienture, LLC is a specialty pharmaceutical company with a team dedicated to bringing unique products to market [11]. Product Details - REZENOPY (naloxone HCl) Nasal Spray 10mg is the most potent version of naloxone available, designed for emergency treatment of opioid overdose [3][7]. - The product is intended for intranasal use and is supplied in a carton containing two blister packages, each with a single spray device [7]. Collaboration and Manufacturing - Kindeva Drug Delivery will manufacture and supply REZENOPY, while Scienture will own the new drug application and handle sales, marketing, and distribution in the U.S. [2]. - This collaboration is seen as a strategic step to enhance public health initiatives and improve access to life-saving interventions for those at risk of opioid overdose [4][6]. Market Context - The nasal delivery of naloxone HCl is recognized for its efficacy and ease of use, making it a vital tool for first responders and healthcare providers [5]. - According to IQVIA data, the total annual sales for naloxone in the U.S. market reached $189 million, with a unit volume of 10 million [5].
SCIENTURE to commercially launch REZENOPY®, a life-saving opioid overdose emergency treatment through a collaboration with KINDEVA DRUG DELIVERY L.P.