Trimel Announces Exclusive License Agreement With Endo for NATESTO(TM) - Seite 2

Safety and efficacy of NATESTO™ in males less than 18 years old have not been established.

Dosage

NATESTO™ for intranasal use is available as a metered-dose pump. One pump actuation delivers 5.5 mg of testosterone. The recommended dose of NATESTO™ is 11 mg of testosterone (two pump actuations, one per nostril), applied intranasally three times daily for a total daily dose of 33 mg.

Contraindications

• Men with carcinoma of the breast or known or suspected prostate cancer
• Pregnant or breast-feeding women. Testosterone may cause fetal harm

Warnings and Precautions

• Nasal adverse reactions: nasal signs and symptoms should be monitored. NATESTO™ is not recommended for use in patients with chronic nasal conditions or alterations in nasal anatomy
• Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH
• Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE
• Women and children should not use NATESTO™
• Exogenous administration of androgens may lead to azoospermia
• Edema with or without congestive heart failure (CHF) may be a complication in patients with pre-existing cardiac, renal, or hepatic disease
• Sleep apnea may occur in those with risk factors
• Monitor serum testosterone, prostate-specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations periodically

Adverse Reactions

The most common adverse reactions (incidence ≥3%) to NATESTO™ observed in clinical trials were an increase in prostate specific antigen (PSA), headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, bronchitis, upper respiratory tract infection, sinusitis and nasal scab.

About Trimel

Trimel is a specialty pharmaceutical company involved in the sale, distribution, and development of products with a focus in men's health, women's health, and respiratory medicine. NATESTO™, a product utilizing Trimel's licensed nasal gel technology, has been approved for sale in the United States by the FDA and is licensed to an affiliate of Endo International plc for commercialization. For more information, please visit www.trimelpharmaceuticals.com.