Latest From Nektar Therapeutics
US FDA's advisors produce tie vote on bupivacaine extended-release solution for post-surgical analgesia; proponents valued its potential to to cut opioid use, while opponents questioned its efficacy.
Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.
But more data on abuse potential and efficacy could offer path for forward for oxycodegol even after the FDA product-specific advisory committee meeting for an opioid analgesic in more than a year goes very badly for the sponsor.
How to score adverse events for Durect's surgical pain treatment could determine whether US FDA advisory committee recommends bupivacaine extended-release solution; agency questions whether Posimir's formulation may cause neurological adverse events.
- Large Molecule
- Drug Delivery
- Therapeutic Areas
- Immune Disorders
- Neurology, Nervous System
- Inhale Therapeutic Systems Inc.
- Nektar Therapeutics Inc.
- North America
- Parent & Subsidiaries
- Nektar Therapeutics
- Senior Management
Howard W Robin, Pres. & CEO
Gil M Labrucherie, SVP, CFO & COO
Stephen K Doberstein, PhD, SVP, R&D and Chief R&D Officer
John Northcott, Chief Commercial Officer
- Contact Info
Phone: (415) 482-5300
455 Mission Bay Blvd. S.
San Francisco, CA 94158
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