Additional use for ospemifene approved by FDA
The FDA has approved the supplemental New Drug Application for the use of ospemifene (Osphena) to add the approved new indication for moderate-to-severe vaginal dryness due to menopause. Ospemifene is an estrogen receptor agonist/antagonist that has selective tissue effects and was initially approved in 2013 for the treatment of moderate-to-severe dyspareunia due to menopause. The additional approval was based on data from a phase III safety and efficacy trial.
Results of the study showed that treatment with ospemifene led to a statistically significant improvement in vaginal dryness, a significant increase in the proportion of superficial cells, and a corresponding statistically significant decrease in the proportion of parabasal cells on a vaginal smear. Mean reduction in vaginal pH between baseline and week 12 was also statistically significant.
Consult the manufacturer's prescribing information for complete product information, including contraindications and the boxed warning for the increased risk of endometrial cancer and cardiovascular disorders. Osphena is a product of Duchesnay USA.
New pediatric dosing options approved for Fluzone Quadrivalent
The FDA approved the expanded use of influenza vaccine (Fluzone Quadrivalent) 0.5 mL to include pediatric patients ages 6 through 35 months. Both the 0.25-mL and 0.5-mL vaccine products will be available for the upcoming 2019/2020 flu season in this age range, according to the manufacturer, Sanofi Pasteur. The convenience of using the same 0.5-mL dose option for children may help streamline immunization efforts, according to Sanofi Pasteur.
The FDA approved the expanded dosing based on the results of a Phase IV safety and immunogenicity study that enrolled more than 2,000 children. The data showed that one or two doses of 0.5-mL vaccine in patients ages 6 through 35 months demonstrated a safety profile similar to one or two doses of 0.25-mL vaccine, with no new safety concerns reported.
Liquid formulation of levothyroxine now available for hypothyroidism
Levothyroxine sodium oral solution (Tirosint-SOL) has been made available by IBSA Pharma for the treatment of hypothyroidism and pituitary thyrotropin suppression. It is the first liquid formulation of levothyroxine approved by the FDA.
Levothyroxine oral solution is available in monodose ampules in 12 different strengths. The oral solution is free from dyes, gluten, lactose, alcohol, sugar, and other excipients that may interfere with absorption. Levothyroxine oral solution can be administered in water or directly into the mouth.
Each ampule has a colored label with the dosage strength and the product name. Levothyroxine oral solution is available immediately through the Tirosint Direct Program from participating pharmacies at a significantly reduced price.
Liquid formulation of colchicine approved for gout flares
The FDA approved ROMEG Therapeutics' colchicine oral solution (Gloperba) for the prophylaxis of gout flares in adults. Gloperba is the first FDA-approved liquid formulation of colchicine approved for prophylaxis of gout flares and is available in a 0.6 mg/5 mL oral solution.
Colchicine has been used for decades to treat gout, but dose adjustments or interruptions of treatment have often been required to address drug interactions or health conditions. Compared with currently available capsule and tablet formulations of colchicine, the new colchicine oral solution allows easy dosage adjustments to be made for patients and is also beneficial for those who cannot swallow solid doses or pills.
Colchicine's approval was based on published evidence from clinical trials supporting the formulation's efficacy in patients with chronic gout. In two randomized clinical trials, treatment with colchicine 0.6 mg twice daily was associated with a decrease in the frequency of gout flares in patients who had gout initiating treatment with urate-lowering therapy. The safety and efficacy of colchicine for acute treatment of gout flares during prophylaxis has not been studied. The formulation should not be used to treat pain from other causes.