Myrbetriq and VESIcare Approved as Combination Therapy
May 7, 2018 – The U.S. FDA has approved Astellas Pharma’s Myrbetriq® (mirabegron) and VESIcare® (solifenacin succinate) to be used in combination for the treatment overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Both medications are approved as individual monotherapies for OAB. Approval for the new indication is based on clinical studies that evaluated the efficacy and safety of combination therapy versus monotherapy and placebo. Although Myrbetriq and VESIcare treat the same condition, each drug does so differently and acts on different receptors in the body that influence bladder function.
OAB affects an estimated 546 million individuals globally. It occurs when the bladder is signaled to contract earlier than necessary, which leads to the sudden and frequent urges to urinate that characterize the condition.
Recommended dosing for combination therapy is 25mg to 50mg of Myrbetriq and 5mg VESIcare once daily. Myrbetriq dosing is based on individual needs and renal health.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.