Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, today affirmed the full availability of Triptodur ® (triptorelin), a twice yearly injectable gonadotropin releasing hormone agonist (GnRHa) for the treatment of pediatric
| ATLANTA, Aug. 25, 2020 /PRNewswire/ -- Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, today affirmed the full availability of Triptodur® (triptorelin), a twice yearly injectable gonadotropin releasing hormone agonist (GnRHa) for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).1 The company confirmed that it has ample supply and also announced it had ordered additional product from their manufacturing partner, Debiopharm, in response to reports of an industry shortage in the United States for a different injection product.
Issued on July 24, 2020 and updated August 17, 2020, the U.S. Food and Drug Administration (FDA) listed Lupron Depot PED, 3 Months, 30 mg as on backorder in its database of Current and Resolved Drug Shortages and Discontinuations Reported to FDA. The listing indicates the estimated duration of this shortage is currently unknown.2 “Arbor Pharmaceuticals is dedicated to ensuring product availability so healthcare providers can prescribe Triptodur with confidence,” said Ed Schutter, CEO of Arbor Pharmaceuticals. “We understand the availability of Triptodur is of the utmost importance during this time, which is why we have requested additional product from our manufacturing partner, Debiopharm, and will be increasing kit production in the U.S.” Triptodur is the first FDA-approved twice-yearly, injectable GnRHa for the treatment CPP.1 Indicated for the treatment of pediatric patients two years of age and older with CPP, Triptodur has been on the market for more than two years, with thousands of prescriptions filled.1,3 Triptodur is manufactured in Martigny, Switzerland in a regularly FDA-inspected site. “We have already implemented new measures to assist with the additional supply of Triptodur treatments,” said Cedric Sager, CEO, Debiopharm Research and Manufacturing SA. “We can assure healthcare professionals and patients in the U.S. that we have a stable supply of Triptodur and do not anticipate any delays or shortages.” “The COVID-19 pandemic has impacted life as we know it, including daily routines,” said Ed Schutter. “But no matter the challenges, compliance to therapy remains a top priority for children living with CPP – which is why we are doing our part to make sure caregivers of CPP patients have the information they need to make informed decisions about their treatment options.” Arbor Pharmaceuticals is committed to helping patients with CPP maintain their prescribed injection schedule. The Triptodur Care Program is available to help healthcare professionals and families of CPP patients receive the access and guidance they need. For more information, contact our live support team at 833-401-CARE (2273) between 8:00 a.m. and 8:00 p.m. ET. Please see Important Safety Information for Triptodur below. For more information about Triptodur, visit https://triptodur.com/. Triptodur is manufactured in Switzerland by Debiopharm Research & Manufacturing SA. Arbor acquired exclusive U.S. commercial rights to triptorelin 6-month for CPP in November 2015 and it was approved by the U.S. FDA in June 2017. About Central Precocious Puberty (CPP) Reliable epidemiological data on CPP worldwide is not available. The condition is a rare disease occurring in about 1 out of every 5,000 to 10,000 children.7 CPP is more common in girls than in boys, with a female: male ratio estimated to be between 3:1 and 23:1.8 About Triptorelin Triptorelin was first registered in France in 1986 and is currently marketed in more than 80 countries for various indications including CPP. About Debiopharm For more information, please visit www.debiopharm.com. About Arbor Pharmaceuticals, LLC IMPORTANT SAFETY INFORMATION FOR TRIPTODUR INDICATIONS TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). IMPORTANT SAFETY INFORMATION Contraindications TRIPTODUR is contraindicated in:
Warnings and Precautions Initial Rise of Gonadotropins and Sex Steroid Levels - During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Therefore, a transient increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses. Psychiatric Events - Psychiatric events have been reported in patients taking GnRH agonists. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with TRIPTODUR. Convulsions - Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including triptorelin. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above. Adverse Reactions In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection). You are encouraged to report side effects of prescription drugs to Arbor Pharmaceuticals, LLC Medical Information at 1-866-516-4950 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. For safety information, consult the TRIPTODUR full Prescribing Information here. References:
PP-TRIP-US-0338
SOURCE Arbor Pharmaceuticals, LLC |
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