Baudette, MN – The FDA has approved ANI Pharmaceuticals, Inc.’s Abbreviated New Drug Application for Oxycodone HCl Capsules, 5mg. Citing IMS Health statistics, the trailing 12-month sales for the product totaled $7.5 million, according to ANI.
A trailing 12-months is a representation of financial performance over a full year. Quarterly and interim reports often show only income from the preceding 3, 6 or 9 months.
Oxycodone hydrochloride is an opioid agonist indicated for the management of moderate to severe acute and chronic pain, conditions suffered by more than 30 percent of Americans.
“When launched, this will be our third commercial Schedule II narcotic product,” Arthur S. Przybyl, ANI’s president and CEO, said in a statement. “In addition, we have received a target action date of January 2, 2017 from the FDA for another Schedule II narcotic product.” He did not identify that product.
Przybyl added that the company hopes to obtain three additional Schedule II narcotic product approvals over the next year.
Schedule II substances have a high potential for abuse, which may lead to severe psychological or physical dependence, according to the nonprofit MedShadow Foundation. Examples include hydromorphone, methadone, meperidine, oxycodone, fentanyl. morphine, opium, and codeine. Other Schedule II substances include amobarbital, glutethimide, and pentobarbital.
The National Institutes of Health (NIH) report that over-reliance on opioid pain reliever prescriptions have resulted in “a national epidemic of overdose deaths and addiction.”
Recent research by the National Institute on Drug Abuse (NIDA) addressed common misconceptions regarding the abuse-related risks of opioid analgesics and highlighted strategies to minimize those risks.
The research, conducted by Nora Volkow, M.D., NIDA director, and A. Thomas McLellan, Ph.D., co-founder and board chair of the Treatment Research Institute, discussed common strategies that can help lessen the risks of opioid abuse, including effective dosing and regular monitoring and assessment.
The authors also recommended increasing medical school training for pain management and addiction, particularly for primary care practitioners who prescribe more than 70 percent of opioid pain relievers. The research was published last month in The New England Journal of Medicine.
ANI specializes in developing, manufacturing, and marketing a range of branded and generic prescription pharmaceuticals, including narcotics, oncolytics, hormones and steroids, and complex formulations involving extended release and combination products.
(Sources: ANI Pharmaceuticals, Inc., MedShadow Foundation, National Instiututes of Health, National Institute on Drug Abuse, Investopedia, LLC, and the Associated Press)