Heron Therapeutics Announces FDA Approval of the Prior Approval Supplement Application for ZYNRELEF® Vial Access Needle ("VAN")

Rhea-AI Summary

Heron Therapeutics (Nasdaq: HRTX) announced FDA approval of the Prior Approval Supplement Application for ZYNRELEF® Vial Access Needle (VAN). The VAN, expected to launch in Q4 2024, aims to simplify aseptic preparation and reduce withdrawal time to 20-45 seconds. It replaces the current vented vial spike with a user-friendly 'container-like' design, potentially enhancing safe use, increasing adoption, and improving preparation.

Bill Forbes, EVP and Chief Development Officer, highlighted the VAN's potential to address adoption hurdles and reduce preparation time. CEO Craig Collard noted that the VAN approval, along with ZYNRELEF's label expansion, inclusion in the proposed 2025 NOPAIN Act, and partnership with CrossLink Life Sciences, are key milestones for ZYNRELEF's progress in 2024.

Positive

• FDA approval of ZYNRELEF® Vial Access Needle (VAN)
• VAN expected to simplify preparation and reduce withdrawal time to 20-45 seconds
• Potential for increased ZYNRELEF adoption and improved preparation process
• ZYNRELEF included in proposed 2025 Non-Opioid Policy for Pain Relief (NOPAIN Act)
• Partnership with CrossLink Life Sciences contributing to ZYNRELEF's progress

Negative

• None.

Insights

Medical Device Expert

The FDA approval of ZYNRELEF's Vial Access Needle (VAN) is a significant development for Heron Therapeutics. This new device addresses key adoption hurdles by simplifying aseptic preparation and reducing withdrawal time to 20-45 seconds. The user-friendly design could enhance safety and improve the preparation process, potentially leading to increased adoption in surgical settings.

The VAN's approval, combined with ZYNRELEF's recent label expansion and inclusion in the proposed NOPAIN Act, strengthens the product's market position. These factors could drive growth in ZYNRELEF's use across various surgical procedures, potentially boosting Heron's revenue in the pain management sector.

However, the Q4 2024 launch timeline means any financial impact won't be immediate. Investors should monitor the VAN's market reception and its effect on ZYNRELEF sales following the launch. The success of this device could be a key factor in Heron's future performance in the competitive postoperative pain management market.

Financial Analyst

This FDA approval represents a positive development for Heron Therapeutics, potentially addressing adoption barriers for ZYNRELEF. The improved ease of use and reduced preparation time could drive increased utilization in surgical settings, potentially leading to revenue growth.

However, investors should note that the financial impact won't be immediate due to the Q4 2024 launch timeline. This gives competitors time to respond and may delay any significant revenue boost until 2025. The company's current market cap of $295 million suggests investors are cautiously optimistic about Heron's prospects.

The inclusion of ZYNRELEF in the proposed NOPAIN Act could provide additional tailwinds if enacted, potentially expanding market access. Investors should monitor the progress of this legislation and its potential impact on ZYNRELEF's market penetration. The partnership with CrossLink Life Sciences may also contribute to improved commercialization efforts, but its impact remains to be seen.

- The VAN has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time

- The VAN is expected to launch in Q4 2024

SAN DIEGO, Sept. 25, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the "FDA") has approved the Company's Prior Approval Supplement Application for ZYNRELEF^® (bupivacaine and meloxicam) extended-release solution VAN.

The VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time down to between twenty and forty-five seconds. The user-friendly "container-like" design of the VAN may enhance the safe use of ZYNRELEF, increase adoption, and improve the preparation process.

"With this approval, we are providing healthcare providers with a new mechanism that directly addresses one of ZYNRELEF's adoption hurdles and will help reduce preparation time for surgical staff," said Bill Forbes, PharmD, Executive Vice President, Chief Development Officer at Heron. "Reducing patients' pain during the first three days after surgery is critical for patient recovery and well-being following often painful procedures, and we anticipate the VAN will lead to increased ZYNRELEF adoption, positively impacting patient recovery."

"The VAN approval, along with ZYNRELEF's January label expansion, its inclusion in the proposed 2025 Non-Opioid Policy for Pain Relief ("NOPAIN Act"), and the continued integration of our partnership with CrossLink Life Sciences, LLC ("CrossLink"), are all exciting milestones achieved during 2024 contributing to ZYNRELEF's continued progress," said Craig Collard, Chief Executive Officer at Heron. "We remain optimistic about the potential transformative impact the VAN will have, following its expected launch in Q4 2024, providing healthcare professionals with an easier to use, versatile, and effective solution for managing postoperative pain across a wide range of surgical procedures."

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Important Safety Information for Patients

ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which:

• can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.
• cannot be used during heart bypass surgery.
• can increase the risk of gastrointestinal bleeding, ulcers, and tears.

ZYNRELEF should also not be used:

• if you are allergic to any component of ZYNRELEF, similar local anesthetics, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines.
• as a paracervical block, during childbirth.

The most common side effects of ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache.

The medicines in ZYNRELEF (a local anesthetic and an NSAID) may affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause adverse effects on cartilage; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia).

Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you.

Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning, at www.ZYNRELEF.com.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit 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. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the potential market opportunities for ZYNRELEF^®, APONVIE^®, CINVANTI^® and SUSTOL^®; revenue, adjusted EBITDA and other financial guidance provided by the Company; the results of the commercial launch of APONVIE; the potential additional market opportunity for the expanded U.S. label for ZYNRELEF; the timing of the Company's development of the VAN program and receipt of required regulatory approvals; the realization of anticipated benefits from receipt of required regulatory approvals and/or launch of the VAN; the Company's ability to establish and maintain successful commercial arrangements like our co-promotion agreement with CrossLink; the realization of anticipated benefits from our co-promotion agreement with CrossLink; the outcome of the Company's pending abbreviated new drug application litigation; whether the Company is required to write-off any additional inventory in the future; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations and the risk that future equity financings may be needed; any inability or delay in achieving profitability. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." 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 and Media Contact:

Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400

 

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SOURCE Heron Therapeutics, Inc.

FAQ

What is the new FDA approval for Heron Therapeutics (HRTX)?

The FDA has approved Heron Therapeutics' Prior Approval Supplement Application for the ZYNRELEF® Vial Access Needle (VAN), which is designed to simplify aseptic preparation and reduce withdrawal time for ZYNRELEF.

When is the ZYNRELEF Vial Access Needle (VAN) expected to launch?

The ZYNRELEF Vial Access Needle (VAN) is expected to launch in Q4 2024.

How does the new Vial Access Needle (VAN) improve ZYNRELEF usage?

The VAN simplifies aseptic preparation, reduces withdrawal time to 20-45 seconds, and features a user-friendly 'container-like' design that may enhance safe use, increase adoption, and improve the preparation process for ZYNRELEF.

What recent milestones has Heron Therapeutics (HRTX) achieved for ZYNRELEF in 2024?

In 2024, Heron Therapeutics achieved VAN approval, ZYNRELEF's label expansion, inclusion in the proposed 2025 NOPAIN Act, and continued integration of their partnership with CrossLink Life Sciences.