Endo will collaborate with Trimel on all regulatory and clinical development activities regarding Natesto, which was approved by the U.S. Food and Drug Administration (FDA) in May of 2014. Endo intends to launch the product, through its Endo Pharmaceuticals subsidiary, in the first quarter of 2015.
About Natesto (testosterone) Nasal Gel
Indications and Usage
Natesto is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including:
- Primary hypogonadism (congenital or acquired)
- Hypogonadotropic hypogonadism (congenital or acquired)
Limitations of Use
- 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 preexisting 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
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.