Arbor Pharmaceuticals, LLC issued the following announcement on Aug. 25.
Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, 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). 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.
"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. 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.
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)
GnRH-dependent CPP is defined by pubertal development occurring before the age of 8 years in girls and 9 years in boys.4-5 It is characterized by early pubertal changes such as breast development and start of menses in girls and increased testicular and penile growth in boys, appearance of pubic hair, as well as acceleration of growth velocity and bone maturation and tall stature during childhood, which often results in reduced adult height due to premature fusion of the growth plates.6
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 is an agonist of the natural GnRH. Debiopharm has developed sustained-release formulations of triptorelin pamoate. The sustained-release formulations have been registered in numerous countries for several indications.
Triptorelin was first registered in France in 1986 and is currently marketed in more than 80 countries for various indications including CPP.
About Debiopharm
Debiopharm, a Swiss-based biopharmaceutical company, aims to manufacture and develop innovative therapies that target high unmet medical needs in oncology and infectious disease. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
For more information, please visit www.debiopharm.com.
We are on Twitter. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews.
About Arbor Pharmaceuticals, LLC
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently marketing FDA-approved prescription products in the neuroscience, cardiovascular and hospital markets. In addition to an extensive pipeline, the company continues to actively pursue growth through acquisition or licensing of late-stage development products. For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com or send email inquiries to medinfo@arborpharma.com.
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:
- Individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.
- Women who are or may become pregnant. Expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to the fetus.
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.
Original source can be found here.
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