Purdue Submits NDA for Hydrocodone Bitartrate Tabs
Purdue Pharma announced that it has submitted a New Drug Application (NDA) to the FDA for once-daily hydrocodone bitartrate tablet (HYD) for chronic pain. This single-entity opioid formulation utilized abuse-deterrent properties intended to make the tablets more difficult to manipulate for the purpose of misuse and abuse by various routes of administration.
Results from the following four studies plus data from additional in vitro abuse-deterrence studies were submitted to the FDA as part of the NDA submission:
“Long-term Safety and Effectiveness of Once-daily, Single-entity, Abuse-deterrent Hydrocodone in Chronic Nonmalignant and Nonneuropathic Pain: Results of a Long-term Open-label Study”
- Persistence of analgesia and improvement in function were achieved with stable HYD doses during maintenance HYD treatment.
- Short‐acting opioid use was stable at a reduced level from screening baseline during the 52‐week HYD treatment period.
“A Single-Center, Randomized, Double-blind Crossover Study to Evaluate the Abuse Potential, Pharmacokinetics and Safety of Intranasally Administered Extended-Release Hydrocodone in Recreational Opioid Users”
- A primary endpoint for the study was drug liking, measured up to 36 hours after dosing using a visual analogue scale (VAS).
- The results showed that tampered HYD (coarse and fine particles) had significantly lower intranasal abuse potential than hydrocodone powder.
“A Single-Center, Randomized, Double-Blind, Crossover Study to Evaluate the Abuse Potential, Pharmacokinetics, and Safety of Oral Intact, Chewed, and Milled Extended-Release Hydrocodone (HYD) Tablets in Recreational Opioid Users”
- The primary endpoint for the study was drug liking, measured up to 36 hours after dosing using a visual analogue scale (VAS).
- Results showed that HYD intact and HYD chewed had significantly lower drug liking scores than hydrocodone solution.
"In Vitro Assessment of the Effects of Alcohol on the Release Rate of Hydrocodone Bitartrate from a Once-daily, Single-Entity, Hydrocodone Bitartrate Formulation"
- Results showed that, as the percentage of alcohol in SGF was increased, the rate of release of hydrocodone from the HYD formulation decreased.
For more information call (888) 726-7535 or visit PurduePharma.com.