Heron Falls After FDA Issues CRL for HTX-011

Shares of Heron Therapeutics are dropping after the company announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.

Shares of Heron have dropped more than 14 percent as of 10:45 a.m. to $18.45. In a brief announcement this morning, Heron said it received the CRL on Tuesday. The letter said the FDA could not approve the NDA in its present form based on the need for additional CMC and non-clinical information. Heron said the FDA did not identify any clinical safety or efficacy issues in the CRL. The regulatory agency will not require further clinical studies or data analyses, Heron said.

"We plan to request a meeting with the FDA to obtain its agreement on our approach to resolve the issues outlined in the CRL and resubmit the NDA as soon as possible," Barry Quart, Heron’s president and chief executive officer said in a statement.

The company did not provide a timeline for how long this could delay HTX-011’s potential entry into the market.

Heron’s HTX-011 is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. Last year, Heron released Phase III data for HTX-011 that showed the therapy hit all primary and key secondary endpoints in two Phase III trials that cut down on the requirement of opioid drugs to treat pain. That positive announcement, of course, comes at a time when the nation is gripped with concerns over opioid abuse. At the time the data was announced, company leaders expressed a belief that HTX-011 could have a significant impact on the opioid crisis by reducing the use of opioids after surgery.

The NDA for HTX-011, which was submitted on Oct. 30, 2018. Two months after that, the FDA granted priority review for HTX-011 and set a PDUFA date of April 30. The FDA had previously granted Breakthrough Therapy designation for HTX-011.

The European Medicines Agency validated Heron’s Marketing Authorization Application for the HTX-011 in April. The validation makes it eligible for the EMA’s Centralized Procedure, which allows applicants to receive marketing authorization valid throughout the European Union. Approval of HTX-011 in Europe is expected in the first half of 2020.

Earlier this year, the FDA did approve Heron's supplemental NDA for Cinvanti (aprepitant) injectable emulsion, for intravenous use. In 2017 the FDA first approved Cinvanti, which is an anti-nausea treatment for cancer patients.