In July 2020 Ferring Pharmaceuticals suspended manufacturing of the nasal spray STIMATE®, a popular product used to treat certain bleeding disorders. The suspension, and subsequent pharmacy level recall, were in response to a packaging seal issue that caused evaporation, a potential hazard to patients who could be exposed to dangerously high concentrations of the product’s active ingredient desmopressin acetate.
A synthetic version of the natural hormone vasopressin, desmopressin (DDAVP) can have multiple impacts on the human body and has often been employed both as an antidiuretic and a clot promoter – DDAVP has capacity to boost both factor VIII and von Willebrand factor levels. Historically, DDAVP has been available in both injectable (subcutaneous) and nasal spray forms to treat nose, mouth, muscle, and joint bleeds, primarily in patients with mild hemophilia A and type 1 von Willebrand disease.
In the nearly three years since the suspension, patients have been treated with other products such as injectable DDVAP or factor replacement therapies, the latter of which are more expensive and can make patients susceptible to an inhibitor. In 2021, a 503B outsourcing facility known as STAQ Pharma began manufacturing a generic desmopressin-based nasal spray in an effort to help fill the gap.
503B entities are “compounding” facilities based at one geographic location, where both sterile and non-sterile medications are compounded. They are registered with U.S. Food and Drug Administration as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act.
Managed Healthcare Executive (MCE) recently posted an update on the current availability of the STAQ product. It includes helpful background information, plus insights on cost, access/reimbursement challenges, and efforts to engage the FDA in broadening the product’s availability.
Much of the context is provided by Joe Pugliese president and CEO of the Hemophilia Alliance, a not-for-profit 501(c)(3) organization that comprises federally funded hemophilia treatment centers that either have, or are seeking to have, pharmacy programs under Section 340B of the Public Health Service Act.
Read the full MCE piece to learn more.
Source: Managed Healthcare Executive, April 25, 2023
