Access to DDAVP Nasal Spray

Background

STIMATE^® has been unavailable to patients since July 2020, when Ferring Pharmaceuticals and CSL Behring announced a voluntary recall of the product. Patient concerns continued when, in February 2021, Ferring Pharmaceuticals stated that it did not anticipate restarting manufacturing and market delivery of STIMATE^® before the second half of 2023, contingent on FDA approval.

Why This Matters

Desmopressin acetate nasal spray has been an important first-line therapy for nearly three decades used in the management of bleeding and facilitating surgical procedures. Alternatives to STIMATE^® include infusion of concentrates of factor VIII, which patients may not know how to self-administer and are typically more expensive. The unavailability of DDAVP nasal spray meant that patients might have to visit emergency rooms or medical offices to obtain treatment for acute bleeding episodes.

New Version of DDAVP now available

With the prospect of a product absence extending beyond 2023, NHF, HFA, and the Hemophilia Alliance successfully petitioned the U.S. Food and Drug Administration to add desmopressin acetate nasal spray to the FDA’s 506E National Drug Shortage list in 2021.

The Hemophilia Alliance then partnered with STAQ Pharma, Inc. — an FDA-registered and FDA-inspected 503B outsourcing facility located in Denver – to produce the appropriate concentration of desmopressin for patient use via nasal spray route of administration. STAQ’s product is now fully licensed in 48 states – and HFA is supporting efforts to get licensure in all 50 states. The Hemophilia Alliance, HFA, and NHF are also working to educate health insurers about the importance of providing coverage for the STAQ-produced nasal spray.

For the Community

Patients should reach out to medical professionals with any personal treatment concerns.

Please note: HFA, NHF, and the Alliance, do not recommend, endorse, or make any representation about the efficacy, appropriateness, or suitability of any specific products, treatments, or opinions. If you have any questions or concerns about your medical treatment, including your possible exposure to recalled products, please consult your physician.