After its expected FDA decision date last week came and went and its shares drove downward premarket Monday morning, Heron Therapeutics has been handed a complete response letter from the FDA.
The rejection is for its troubled drug HTX-011, a long-acting formulation of a bupivacaine solution combined with anti-inflammatory medication meloxicam. In several trials released over the past few years, the drug has shown it can significantly reduce pain intensity and decrease opioid use for 72 hours after surgery.
The drug is administered using the company’s proprietary biochronomer delivery tech, which the company also uses in its two approved injectable therapies, Sustol and Cinvanti, each of which address one of the primary mechanisms of chemo-induced nausea and vomiting.
It's also a non-opioid treatment, making it ostensibly more attractive to doctors and regulators looking to wean patients off potentially addictive meds that have led to a major uptick in abuse and deaths in recent years.
This CRL is, in fact, the second time in a year Heron has been slapped with a no from the FDA: Last April, the San Diego biotech saw the drug’s first rejection, then specifically asking for additional chemistry manufacturing and controls info.
Today, the company said the issues were nonclinical and not related to safety or CMC, but rather to four nonclinical issues.
Three relate to “confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage,” the company said in a statement.
The drug’s PDUFA date had been June 26, itself a 3-month extension of its original speedy review.
“We do not believe that any of the issues are significant barriers to ultimate approval, as all of the excipients have extensive histories of use in pharmaceuticals and the specification can be revised. The Company will request a Type A meeting to obtain agreement with the Agency on our responses and resubmit the application as quickly as possible.”