Heron Therapeutics, Inc. (HRTX - Free Report) announced that the FDA issued a complete response letter (“CRL”) to its new drug application (“NDA”) seeking approval for its pipeline candidate, HTX-011. The NDA sought approval for the candidate for the management of postoperative pain.
Shares of Heron plunged 28.1% on Monday, following the announcement of the CRL. The company’s shares have lost 39.4% so far this year compared with the industry’s decline of 7.3%.
The CRL issued by the regulatory authority raised four non-clinical issues. Among these issues, three were related to confirming exposure of excipients in preclinical reproductive toxicology studies. Another issue relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage. However, there were no clinical safety or efficacy issues or chemistry, manufacturing and control (“CMC”) issues. The FDA has requested additional non-clinical information. The FDA does not require any further study to be conducted
The company believes none of the issues stated in the CRL are significant barriers for a potential approval. Heron will request a type A meeting with the FDA to discuss issues and obtain agreement with the agency with its responses and resubmit the NDA as quickly as possible.
We note that the NDA for HTX-011 was previously issued another CRL in April 2019, in which also the FDA had requested additional CMC and non-clinical information. Heron resubmitted the NDA in September last year. In February 2020, the FDA extended the review period for the HTX-011 NDA by three months. However, there was no reason mentioned for the extension. The earlier CRL has already delayed the approval of HTX-011 by more than a year.
Please note that the NDA included data from five phase II clinical studies and two phase III clinical studies. Data from the various studies showed that HTX-011 was more effective in reducing pain than placebo or bupivacaine alone, the current standard-of-care, in five diverse surgical models — hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation.
HTX-011 utilizes Heron's proprietary Biochronomer drug delivery technology, a long-acting, extended-release formulation of the local anesthetic bupivacaine, a non-opioid, in a fixed-dose combination with the anti-inflammatory meloxicam. The candidate is designed to address both postoperative pain and inflammation in a single administration at the surgical site. Moreover, HTX-011 has demonstrated significant reduction in pain and opioid use in a phase III study through 72 hours compared to bupivacaine solution for postoperative pain control.
We note that a potential approval will be a significant boost for the company. There is a great need for safe, effective and non-addictive options that can decrease opioid exposure, given the epidemic of opioid abuse that has put companies like J&J (JNJ - Free Report) Endo International (ENDP - Free Report) and Mallinckrodt (MNK - Free Report) , among others under the microscope.
Heron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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