Full Press Release Details
Issues Reminder of Non-Substitution of PEDMARK
(sodium thiosulfate injection) for
Pediatric Patients Receiving Cisplatin
TRIANGLE PARK, N.C., February 1, 2024 - 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.
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:
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.
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.
information, please contact:
Chief Financial Officer
Fennec Pharmaceuticals Inc.
Corporate and Media:
Elixir Health Public Relations