A randomized, double-blind, placebo-controlled, six-sequence crossover study evaluating the relative oral abuse potential of NKTR-181 compared to the Schedule II opioid oxycodone in healthy non-dependent recreational drug users experienced in the oral abuse of opioids who can identify drug effects that are relevant to abuse risk assessment
Phase of Trial: Phase II
Latest Information Update: 30 Jul 2018
At a glance
- Drugs NKTR 181 (Primary) ; Oxycodone
- Indications Back pain; Musculoskeletal pain; Pain
- Focus Pharmacokinetics; Registrational
- Acronyms HAP
- Sponsors Nektar Therapeutics
- 30 Jul 2018 According to a Nektar Therapeutics media release, the U.S. FDA has filed and accepted for review of the companys NDA for NKTR-181 for the treatment of chronic low back pain in adult patients new to opioid therapy. The NDA is expected to be assigned a PDUFA (Prescription Drug User Fee Act) target action date of 28 May 2019 by the FDA.
- 31 May 2018 According to a Nektar Therapeutics media release, the company has submitted a NDA to the US FDA for NKTR-181, a first-in-class investigational opioid to treat chronic low back pain in adult patients new to opioid therapy, based on the data of: Efficacy study (243040); a long-term 52-week safety study (254129); pharmacokinetic/pharmacodynamic studies in over 450 subjects; and two human abuse potential studies of NKTR-181 versus an oxycodone control in recreational drug users (220652 and 282808)
- 10 May 2018 According to an Nektar Therapeutics media release, data will be presented at the American Society for Clinical Oncology (ASCO) 2018 Annual Meeting.