Tolmar Publishes FENSOLVI ® (leuprolide acetate) for Injectable Suspension Safety and Efficacy Data in Journal of Clinical Endocrinology and Metabolism
- Phase 3 Study shows the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty (CPP) -
Nov 24, 2020, 08:52 ET
BUFFALO GROVE, Ill., Nov. 24, 2020 /PRNewswire/ -- Tolmar Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced the publication of an open-label, single arm, multicenter Phase 3 study on the efficacy, safety, and pharmacokinetics of Fensolvi® (leuprolide acetate) for injectable suspension for patients with Central Precocious Puberty.
The study, published in the Journal of Clinical Endocrinology and Metabolism, evaluated 45-mg subcutaneous leuprolide acetate administered at a 6-month interval in 64 GnRHa-naïve children with CPP. Fensolvi effectively suppressed reproductive hormones and stopped or caused regression of pubertal progression. This long-acting GnRHa preparation of leuprolide acetate in a 6-month dose, subcutaneous injection format is a new, effective, and well-tolerated therapy for children with CPP approved by the Food and Drug Administration (FDA) in May 2020.
"The most important treatment objectives in children with CPP include suppressing pubertal hormones to stop the progression of physical signs of puberty, and slowing the rate of bone maturation to improve height outcome," said Karen O. Klein, M.D., board-certified pediatric endocrinologist at Rady Children's Hospital-San Diego and Clinical Professor of Pediatrics at UC San Diego School of Medicine.
Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of pediatric patients two years of age and older with central precocious puberty. Fensolvi utilizes an innovative proprietary polymeric gel technology that forms an in-situ solid after injection and releases leuprolide acetate in a sustained and controlled manner over time. This polymeric gel technology enables subcutaneous injection of a small volume of only 0.375mL, with a short 5/8-inch needle, and a twice-yearly dosing cycle.
"This study reflects Tolmar's ongoing commitment to increased understanding of therapy across the continuum of central precocious puberty through research and peer-reviewed publications," said Stuart Atkinson, MB ChB, Vice President Medical Affairs, Tolmar Pharmaceuticals, Inc.
About Central Precocious Puberty (CPP)
Gonadotropin releasing hormone (GnRH)-dependent central precocious puberty (CPP) is the premature development of signs of sexual maturation occurring in girls younger than eight and in boys younger than nine years of age. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological and emotional issues, including lower self-esteem, stress, anxiety and depression. CPP is believed to have a five- to twenty-fold higher incidence in girls than in boys and is estimated to occur in one in 5,000-10,000 children.
About Fensolvi® (leuprolide acetate) for injectable suspension
Fensolvi (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients two years of age and older with CPP. It is a prescription drug, given by injection.
Fensolvi is the first and only six-month, subcutaneous leuprolide acetate with a small injection volume that allows flexibility in selection of injection site and enables administration in an office setting. Fensolvi represents an effective, safe and convenient treatment option for this vulnerable patient group, and its profile aligns with twice-yearly visits to the pediatric endocrinologist's office.
Information about Fensolvi is available at fensolvi.com.
About Tolmar Pharmaceuticals
"Tolmar" refers to Tolmar Holding, Inc. and its wholly owned operating subsidiaries, Tolmar Inc., Tolmar Therapeutics, Inc., and Tolmar Pharmaceuticals, Inc. Tolmar global headquarters, product development and manufacturing facilities are based in northern Colorado, while Tolmar Pharmaceuticals' U.S. commercial business is based in Buffalo Grove, Illinois. For more information about the company, please visit tolmar.com
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Important Safety Information for FENSOLVI® (leuprolide acetate)
FENSOLVI® (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP). CPP may be diagnosed when signs of sexual maturity begin to develop in girls under the age of 8 or in boys under the age of 9.
FENSOLVI is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, in individuals who are allergic to any of the ingredients in FENSOLVI, or in individuals who are pregnant. FENSOLVI may cause fetal harm when administered to a pregnant patient.
During the first few weeks of treatment, increases in gonadotropins and sex steroids above baseline may result in an increase in signs and symptoms of puberty including vaginal bleeding in girls.
Psychiatric events have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Patients should be monitored for development or worsening of psychiatric symptoms.
Convulsions have been observed in patients treated with GnRH agonists with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs.
The most common adverse events seen with FENSOLVI were: injection site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough and hot flush.
Please see Full Prescribing Information for additional important safety information.
To report suspected adverse reactions contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
SOURCE Tolmar Pharmaceuticals
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