FDA Issues Reminder of Non-Substitution of PEDMARK® (sodium thiosulfate injection) for Pediatric Patients Receiving Cisplatin

Rhea-AI Summary

Fennec Pharmaceuticals Inc. announced that the U.S. FDA issued a public reminder to healthcare providers about the non-substitutability of PEDMARK with other sodium thiosulfate products. The FDA highlighted potential health risks associated with such substitutions, emphasizing the unique characteristics of PEDMARK. This communication aims to protect pediatric patients with localized, non-metastatic solid tumors from ototoxicity linked to cisplatin treatment.

Medical Research Analyst

The recent FDA reminder regarding the non-substitutability of Fennec Pharmaceuticals' PEDMARK with other sodium thiosulfate products is a critical piece of information for healthcare providers and patients. PEDMARK's unique formulation is designed to mitigate ototoxicity in pediatric patients undergoing cisplatin chemotherapy, which is a significant advancement in supportive cancer care. The specificity of the formulation, which avoids certain excipients like potassium chloride and sodium nitrite, is essential for its safety and efficacy profile.

From a research perspective, this highlights the importance of adhering to FDA-approved therapies, especially when they have been tailored to reduce risks associated with treatments. It also underscores the potential dangers of substituting medications without regulatory approval, which can result in exposure to harmful substances and adverse health outcomes. For stakeholders, this serves as a reminder of the rigorous standards required for drug formulation and the potential liabilities of not following FDA guidelines.

Pharmaceutical Market Analyst

In terms of market impact, the FDA's public reminder could reinforce the market position of PEDMARK by emphasizing its unique formulation and the risks associated with substituting non-approved alternatives. It might potentially lead to an increase in demand for PEDMARK, as it clearly differentiates the product from other sodium thiosulfate-based treatments. For investors, this development could be seen as a positive reinforcement of the company's product value proposition and its regulatory compliance.

Moreover, this communication may influence prescribing habits, as providers might be more cautious about off-label use of similar compounds. This could translate into more consistent sales for PEDMARK, provided that healthcare providers adhere to the FDA's guidance. In the long term, this could also impact the company's reputation positively, as it demonstrates a commitment to patient safety and regulatory adherence.

Legal Expert

The legal implications of the FDA's reminder are significant for both healthcare providers and the pharmaceutical company. For providers, non-compliance with FDA directives can result in legal and ethical consequences, including malpractice claims if patient harm results from off-label use. For Fennec Pharmaceuticals, this announcement serves as a protective measure against potential litigation, as it clearly communicates the approved use of its product and the risks of deviation from the prescribed treatment.

Furthermore, the specificity of the FDA's communication serves as a legal endorsement of PEDMARK's proprietary formulation and reinforces the importance of intellectual property rights in the pharmaceutical industry. By highlighting the unique aspects of PEDMARK, the FDA is indirectly supporting the company's market exclusivity for this particular indication, which can have long-term financial benefits for the company.

RESEARCH TRIANGLE PARK, N.C., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a public reminder to healthcare providers that PEDMARK (sodium thiosulfate injection) is not substitutable with other sodium thiosulfate products as explicitly directed in its prescribing label. PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

The FDA stated in the public communication that it is aware that some providers may be preparing other sodium thiosulfate (STS) products for patient use in place of PEDMARK, including diluting STS products approved for other uses to match the strength of PEDMARK. The FDA reminded health care providers that as stated in PEDMARK’s prescribing information, PEDMARK is not substitutable with other sodium thiosulfate products. The FDA stated that such substitutions pose potential health risks, including:

• Potassium chloride exposure which, at high doses, can lead to increased risk of acute cardiac events and other serious adverse reactions. Potassium chloride is not present in PEDMARK.
• Overexposure to boric acid (a boron compound), can cause health risks including headache, hypothermia, restlessness, weariness, renal injury, dermatitis, alopecia, anorexia and indigestion. Although PEDMARK also contains boric acid, it is at a lower concentration than other STS products.
• Overexposure to sodium nitrite, which can lead to health risks including methemoglobinemia. Sodium nitrite is co-packaged with sodium thiosulfate as a separate vial in some products; it is not present in PEDMARK.
  

The public communication was issued by the FDA’s Professional Affairs and Stakeholder Engagement Staff within the Center for Drug Evaluation and Research, Office of Communications. The FDA encourages those with any questions to contact FDAOncology@fda.hhs.gov.

About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK^® and Pedmarqsi to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK received FDA approval in September 2022 and European Commission Marketing Authorization in June 2023 for Pedmarqsi. PEDMARK has received Orphan Drug Exclusivity in the U.S. for seven years of market protection and Pedmarqsi has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the reduction of risk of ototoxicity induced by platinum chemotherapy, in humans. For more information, please visit www.fennecpharma.com.

For further information, please contact:

Investors:
Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299

Corporate and Media:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
lrocco@elixirhealthpr.com

What is the FDA's reminder about PEDMARK?

The FDA reminded healthcare providers that PEDMARK is not substitutable with other sodium thiosulfate products, emphasizing the potential health risks associated with such substitutions.

What is the indication for PEDMARK?

PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

What are the potential health risks associated with substituting PEDMARK with other sodium thiosulfate products?

The potential health risks include potassium chloride exposure, overexposure to boric acid, and overexposure to sodium nitrite, all of which are not present in PEDMARK or present at lower concentrations compared to other STS products.

Who issued the public communication about PEDMARK?

The public communication was issued by the FDA’s Professional Affairs and Stakeholder Engagement Staff within the Center for Drug Evaluation and Research, Office of Communications.