FDA Rejects Abuse-Deterrent Oxycodone – Pharmacy Times

Officials with the FDA have rejected Intellipharmaceutics’ abuse-deterrent Oxycodone Hydrochloride Extended-Release Tablets (Rexista), the company announced in a press release.

A Complete Response Letter (CRL) from the agency stated that further evidence is needed to prove the drug’s abuse-deterrent potential for oral and nasal routes of administration. The FDA has requested that Intellipharmaceutics’ complete the relevant category 2 and category 3 studies (more…)