Orexo AB announced Tuesday that it has begun the launch of a new higher dosage of ZUBSOLV, a drug designed to help battle opioid dependence, that was recently issued a new U.S. patent.
The new 8.6 dosage accompanies the existing dosage range of 5.7 mg/1.4 mg and 1.4 mg/.36 mg, therefore allowing patients to receive the ideal dose in one tablet. The U.S. Food and Drug Administration approved two new ZUBSOLV dosage strengths in December. Orexo decided to begin distribution of the 8.6 mg dose after receiving the final clearance of the REMS material. The new strength is anticipated to be available in the first half of March.
The United States Patent and Trademark Office issued a new patent in January that protects ZUBSOLV (U.S. Patent No. 8,940,330). The patent expires Sept. 18, 2032 and is the fourth patent listed in the Orange Book by the FDA that covers ZUBSOLV.
“The continued development of the ZUBSOLV product range is a core element of Orexo’s strategy,” Nikolaj Sørensen, CEO and president of Orexo, said. “We invest significant resources in developing the product through clinical research and pharmaceutical development to the benefit of patients suffering from opioid dependence. A solid patent protection platform is essential to enable these investments. With this latest patent, we gain additional confidence and commitment to our continued efforts to improve the treatment of opioid dependence.”
Orexo US, Inc. is an emerging specialty pharmaceutical company