Heron Therapeutics Receives Complete Response Letter for HTX-011 for the Management of Postoperative Pain

Rhea-AI Summary

Heron Therapeutics (Nasdaq: HRTX) announced on June 29, 2020, that it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for HTX-011, aimed at managing postoperative pain. The CRL cited the need for additional non-clinical information but did not find any clinical safety or efficacy issues. Heron plans to address these issues and resubmit the application. HTX-011 is a non-opioid analgesic that has shown promise in reducing pain and opioid use in clinical trials.

Positive

• No clinical safety or efficacy issues identified by the FDA.
• HTX-011 demonstrated significantly reduced pain and opioid use in Phase 3 studies.

Negative

• Received a Complete Response Letter (CRL) from the FDA requiring additional non-clinical information.
• Potential delays in market entry for HTX-011 due to the CRL.

SAN DIEGO, June 29, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on June 26, 2020 regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.

The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or CMC issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity. 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. 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.

"We are committed to resolving the non-clinical issues outlined in the CRL with the FDA and resubmitting an NDA as soon as possible to bring this important non-opioid analgesic to patients," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron.

Conference Call and Webcast

Heron will host a conference call and webcast today, June 29, 2020, at 9:00 a.m. ET (6:00 a.m. PT). The conference call can be accessed by dialing 877-311-5906 for domestic callers and 281-241-6150 for international callers. Please provide the operator with the passcode 3252267 to join the conference call. The conference call will be available via webcast under the Investor Relations section of Heron's website at -1%26h%3D1353068250%26u%3Dhttp%253A%252F%252Fwww.herontx.com%252F%26a%3Dwww.herontx.com&a=www.herontx.com" rel="nofollow">www.herontx.com. An archive of today's teleconference and webcast will be available on Heron's website for 60 days following the call.

About HTX-011 for Postoperative Pain

HTX-011, an investigational non-opioid, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted a New Drug Application (NDA) to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on June 26, 2020 relating to non–clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. For more information, visit -1%26h%3D3418578330%26u%3Dhttp%253A%252F%252Fwww.herontx.com%252F%26a%3Dwww.herontx.com&a=www.herontx.com" rel="nofollow">www.herontx.com.

Forward-looking Statements

This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those associated with: whether the U.S. Food and Drug Administration (FDA) approves the New Drug Application (NDA) for HTX-011; the timing of the commercial launch of HTX-011; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; the timing of Health Canada's New Drug Submission (NDS) review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

Investor Relations Contact:

David Szekeres
Chief Legal, Business and Administrative Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447

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SOURCE Heron Therapeutics, Inc.

FAQ

What is the reason for the Complete Response Letter to Heron Therapeutics regarding HTX-011?

The FDA's Complete Response Letter stated that additional non-clinical information is required before approval.

Did the FDA identify any clinical safety issues with HTX-011?

No, the FDA did not find any clinical safety or efficacy issues related to HTX-011.

What steps is Heron Therapeutics taking after receiving the CRL for HTX-011?

Heron Therapeutics plans to resolve the non-clinical issues and resubmit the NDA to the FDA as quickly as possible.

What type of drug is HTX-011?

HTX-011 is a dual-acting, non-opioid analgesic combining bupivacaine and meloxicam.

When did Heron Therapeutics submit the original NDA for HTX-011?

Heron submitted the New Drug Application (NDA) for HTX-011 in October 2018.