PainReform has received FDA approval to conduct two pivotal Phase III clinical trials for post-operative pain relief in soft and hard tissue.
"This green light from the FDA enables us to progress towards receiving an NDA (New Drug Approval) for the general use of our breakthrough technology in post-operative extended pain relief," said Dr. Eli Hazum, CEO of PainReform.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
The trials will use PRF-110, a proprietary extended release version of ropivacaine (Naropin) which provides long relief of post-surgical incision pain. In a Phase II study, PRF-110 demonstrated pain relief for up to 72 hours – ten times longer than the current standard of care.
PRF-110 has the complete set of attributes, including efficacy, safety, physical properties and low-cost, to position it as the leading candidate to carve out the biggest share of this very large market.
The estimated market potential for pain relief drugs is $5 billion. The current medical habit of resorting to opiate-based narcotics is identified by FDA as an epidemic with substantial health complications and addiction of patients – and their resultant costs.