New Treatments
Nektar Therapeutics (NKTR-181)
- NKTR-181 is a new chemical entity (NCE) designed to relive pain without inducing high levels of euphoria, minimising the likelihood of addiction and abuse. Due to the potential of NKTR-181 to address the urgent problem of prescription painkiller abuse, the US Food and Drug Administration (FDA) granted NKTR-181 a Fast Track designation for the treatment of moderate-to-severe chronic pain in May 2012.
- March 20 2017, Nektar Therapeutics announced positive results from the SUMMIT-07 Phase III study testing the efficacy of NKTR-181 in the management of moderate-to-severe chronic lower back pain.
- Trial: SUMMIT-07, ClinicalTrials.gov Identifier: NCT02362672
- Human Abuse Potential of Oral NKTR-181 in Recreational Opioid Users: A Randomized, Double-Blind, Crossover Study
- May 2019, spinning off into a new subsidiary, Inheris Biopharma
- July 26 2019
- FDA Delays Advisory Committee Hearing For NKTR-181
- Jefferies’ David Steinberg says he now expects a 1-year delay for the entry of the drug and lop off 30% of its peak revenue — trimming that to $350 million.
- Q3 earnings Call, Nov 6 & Jefferies London Healthcare Conference, Nov 20
- FDA informed us that they can now reschedule product-specific advisory committee meetings. We now anticipate adcomm for NKTR-181 within the next several months
- https://seekingalpha.com/article/4303473-nektar-therapeutics-nktr-ceo-howard-robin-q3-2019-results-earnings-call-transcript?part=single