NHF Responds to STIMATE® Production Update
CSL Behring announced that the company’s distribution agreement with Ferring Pharmaceuticals for STIMATE® nasal spray recently expired and will not be renewed effectively removing this medication as a valuable treatment option for patients with von Willebrand Disease (VWD) and mild hemophilia A.
For over a year now, STIMATE® has been unavailable to patients, creating hardship. In July of 2020, Ferring Pharmaceuticals and CSL Behring first announced a pharmacy level recall. 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. Today’s announcement, however, means that, whenever Ferring does resume manufacturing desmopressin acetate nasal spray, CSL Behring will not be the distributor of that product and Ferring will need to identify another distribution partner for the U.S.
Why This Matters
The nation’s leading advocacy organizations for the inheritable blood disorders community — HFA, NHF, and the Hemophilia Alliance — are united in their concern about access to and availability of alternative treatments for patients who rely on desmopressin acetate nasal spray for the treatment of their disorders.
This product 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. Pandemic circumstances, of course, heighten the difficulty for patients who may now need to visit emergency rooms or medical offices to obtain treatment for acute bleeding episodes.
With the prospect of a product absence extending well into 2023, NHF, HFA, and the Hemophilia Alliance have successfully petitioned the U.S. Food and Drug Administration to add desmopressin acetate nasal spray to the FDA’s 506E National Drug Shortage list as of earlier this year. Together, the organizations are actively working to find suitable, approved, safe treatment options for all patients in need.
To secure a new desmopressin nasal spray that could meet patients’ needs, STAQ Pharma, Inc. — an FDA-registered and FDA-inspected 503B outsourcing facility located in Denver – has been asked to produce the appropriate concentration of desmopressin for patient use via nasal spray route of administration. STAQ has produced a product that has successfully passed the 75-day stability mark and plans to start shipping this month. The product is presently available in 31 states and may be purchased from STAQ by any pharmacy. We are working with STAQ to get licensure in all 50 states. We will update you as the dating improves and the product becomes more widely available. However, reimbursement for the product has not been confirmed by all health plans. NHF, HFA, and the Hemophilia Alliance continue to work on this issue. Read more on this initiative with STAQ here: https://hemoalliance.org/may-2021-newsletter/.
For the Community
Patients should, in the meantime, reach out to medical professionals with any personal treatment concerns.
Please note that 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.
To read the announcement from CSL Behring, click here.
Source: National Hemophilia Foundation, September 2021