Ardelyx, Inc., a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.
Previously, Ardelyx announced that the FDA approved XPHOZAH® (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway. Ardelyx has identified 550,000+ patients with CKD on dialysis in U.S., 80% of which require Rx treatment for hyperphosphatemia.
Ardelyx has selected 11 specialty pharmacies as limited distribution partners for XPHOZAH. National partners include:
- Premier Pharmacy Services is a specialty pharmacy servicing patients nationwide. They are headquartered in Baldwin Park, California, with additional locations in Missouri, Pennsylvania, and New Jersey. With over 600 team members working around the clock 365 days a year to serve patients, Premier ensures the best clinical outcomes by building customized programs around patients individual disease states.
- Synergen Rx Pharmacy’s staff has extensive experience across all specialty disease states as well as expert knowledge in navigating the approval process.
- Perigon Pharmacy 360 (not a partner for XPHOZAH in California) is an independent specialty pharmacy that is working to provide care and support to those in need. Perigon serves patients in all 50 states, plus D.C., and is focused on helping improve the patient experience through access to medications, caregiver awareness, provider engagement, and clinical support of its Care Teams.
- LifeLine Specialty Pharmacy (not a partner for XPHOZAH in California) is committed to patient care and patient education. In patient care the pharmacy does believe being an integral part of the healthcare team it is its responsibility for the outcomes associated with medication use.
Takeaway: AMI’s Specialty Pharmacy Database includes the list of limited distribution partners for hundreds of specialty pharmaceuticals as well as additional comprehensive information on 1,600 specialty pharmacies