Vaginal Insert Supports Implantation
Endometrin, a new micronized progesterone vaginal insert, has been approved to support embryo implantation and early pregnancy by supplementation of corpus luteal function. The new insert, a product of Ferring Pharmaceuticals, is intended to be part of an assisted reproductive technology treatment of infertile women.
The 100 mg insert is administered by disposable applicator two or three times daily beginning at oocyte retrieval and continuing for up to 10 weeks. Vaginal absorption of Endometrin has been shown to lead to high tissue yields of progesterone at the endometrium as well as measurable serum levels.
Data from clinical trials show that twice-daily use of Endometrin produced mean endometrial tissue progesterone concentrations that were 10 times greater than those with 50 mg progesterone intramuscular injection. The implant is an alternative to progesterone suppositories, which can be messy and leaky; painful injections; and oral and vaginal tablets that are considered less effective than other forms of progesterone.
Adverse reactions in clinical trials of Endometrin included uterine spasm and vaginal bleeding as well as breast tenderness, bloating, mood swings, and irritability.
Pulmonary Arterial Hypertension Treatment
The FDA has approved ambrisentan (Letairis) for the treatment of pulmonary arterial hypertension (PAH). The medication is a product of Gilead Sciences. Ambrisentan is similar to an existing medication but offers the potential for fewer drug interactions, according to the FDA. The drug is approved for patients with PAH who are in World Health Organization symptom class II or III.
Ambrisentan is available in 5 mg and 10 mg once-daily tablets.
The safety and effectiveness of ambrisentan was shown in two clinical trials involving 393 patients. Ambrisentan significantly improved physical activity capacity compared with placebo and delayed the worsening of PAH. The most common side effects associated with the medication were ankle swelling, nasal congestion, sinusitis, and flushing.
This medication should not be used by women who are pregnant or can become pregnant because it has the potential to cause birth defects. Patients taking ambrisentan must also have monthly blood tests to check for liver damage.
Rimantadine May Interfere with FluMist
The FDA has made alterations in the labeling of rimantadine (Flumadine tablets and syrup) to warn of a potential interaction with FluMist intranasal trivalent live influenza virus vaccine. According to the agency, there is a potential for interference when the two products are administered concurrently because rimantadine may inhibit the replication of live vaccine virus.
The FDA advises that a 48-hour period elapse between the end of antiviral therapy and the administration of the vaccine. A 2-week lapse is advised after vaccination and before initiation of antiviral therapy.
Extended-Release Asthma Medication Approved
The FDA approved an extended-release 600 mg tablet formulation of zileuton (Zyflo CR) for the prophylaxis and long-term treatment of asthma in patients ages 12 years and over. The new formulation is a product of Critical Therapeutics and is copromoted with Dey LP.
This medication is not indicated for use in treating bronchospasms in acute asthma attacks.
The recommended dosage of extended-release zileuton is two 600 mg tablets twice daily, taken within 1 hour after morning and evening meals.
The most common adverse events reported in studies included sinusitis, nausea, and pharyngolaryngeal and abdominal pain. Use of zileuton extended-release is contraindicated in patients with active liver disease or persistent hepatic enzyme level elevations greater than 3 or more times the upper limit of normal.