Developing non-opioid pain drugs: Companies question if FDA is raising the bar
As the opioid epidemic rages on in the US, taking the lives of more than 100,000 people in the last year alone, companies developing new non-opioid pain drugs are questioning the FDA on its new draft guidance.
The draft in question, released in February, provides industry with some parameters around which it can work to develop these potentially less addictive pain meds. The guidance addresses FDA’s current thinking on 3 specific topics: development of non-opioid analgesics for acute pain, labeling claims and expedited programs.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.