Shots:

• The approval is based on P-III development program assessing Olinvyk in <1-500 patients with moderate to severe acute pain. The loading dose for all Olinvyk treatment regimens (1.5 mg); demand dose (0.1-0.35-0.5mg); and supplemental dose (0.75 mg)
• Result: Olinvyk demonstrated rapid analgesic efficacy statistically significant vs. PBO. Patients using the Olinvyk (doses of 0.35 and 0.5 mg) had a statistically significantly greater SPID-48/24 than patients using PBO
• Olinvyk is a new chemical entity approved in adults for the management of acute pain severe enough to require an IV opioid analgesic. Olinvyk’s product availability is expected in Q4’2020 after the issuing of controlled substance schedule by the US Drug Enforcement Administration (DEA)

­ Ref: The Pharma Letter | Image: The Pharma Letter