Troxyca ER (oxycodone/naltrexone) / Pfizer - LARVOL DELTA

Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials. (PubMed, Curr Med Res Opin) - P3 | " The safety and tolerability of ALO-02 is similar in those aged ≥65 years and those aged <65 years with chronic pain. ClinicalTrials.gov identifiers: NCT01571362, NCT01428583."

Journal • Retrospective data • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Oncology • Pain

Healthy volunteers study to estimate the effects of food on the bioavailability of oxycodone and naltrexone/6- Β -naltrexol from a extended release formulation of oxycodone with sequestered naltrexone (clinicaltrials.gov) - P1, N=24; Recruiting -> Active not recruiting

Enrollment closed • Pain

Pfizer announces FDA advisory committees’ recommend ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for approval (Businesswire) - "Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted (9 to 6) in favor of approval of ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for its proposed indication, 'management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate."

FDA event • Demo Pain • Pain

Pfizer reports fourth-quarter and full-year 2015 results (Businesswire) - "The FDA has not taken action on Pfizer’s New Drug Application (NDA) for ALO-02, which had a PDUFA date in January 2016. The delay is not related to anything specific in the ALO-02 NDA, and no additional data analyses or data requests have been identified by the FDA. Pfizer is continuing discussions with the FDA to finalize the label. Pfizer cannot speculate on timing for the FDA decision."

Pipeline update • Pain

FDA approves Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules CII with abuse-deterrent properties for the management of pain (Businesswire) - "Pfizer...announced today that the U.S. Food and Drug Administration (FDA) has approved TROXYCA® ER...capsules, for oral use, CII for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. TROXYCA ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes."

NDA • Demo Pain • Pain

Effects of naltrexone exposure observed in two phase three studies with ALO-02, an extended-release oxycodone surrounding sequestered naltrexone. (PubMed, J Opioid Manag) - P3; "Naltrexone plasma concentrations were low, not correlated with COWS or BPI-sf scores, and considered clinically insignificant."

Journal • P3 data

Effects of intravenous oxycodone alone or in combination with naltrexone on measures of respiratory depression: a randomized placebo-controlled study. (PubMed, Ther Adv Drug Saf) - "E values were significantly lower for oxycodone 20 mg + naltrexone 2.4 mg versus oxycodone 20 mg (p = 0.0005), and not different from placebo (p > 0.05). This abuse-potential study suggests that naltrexone released from ALO-02 tampering by crushing attenuates oxycodone-induced increase of EtCO in nondependent recreational opioid users."

Clinical • Combination therapy • Journal