Medication Monitor

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  • August 28, 2018

    FDA has approved cenegermin, the first drug for treatment of neurotrophic keratitis, a rare disease affecting the cornea.

    Neurotrophic keratitis is a degenerative disease resulting from a loss of corneal sensation. The loss of corneal sensation impairs corneal health, causing progressive damage to the top layer of the cornea, including corneal thinning, ulceration, and perforation in severe cases. Prevalence of neurotrophic keratitis has been estimated to be fewer than 5 in 10,000 individuals.

    Safety and efficacy were studied in 151 patients with neurotrophic keratitis in two randomized, controlled, multicenter, double-masked studies lasting 2 weeks.

    Across both studies, complete corneal healing in 8 weeks was demonstrated in 70% of patients treated with cenegermin compared with 28% of patients treated without cenegermin.

    The most common adverse reactions in patients taking cenegermin are eye pain, ocular hyperemia (enlarged blood vessels in the white of the eyes), eye inflammation, and increased lacrimation (watery eyes).

  • August 20, 2018

    Sun Pharma announced FDA approval of cyclosporine ophthalmic solution 0.09% to increase tear production in patients with keratoconjunctivitis sicca (dry eye).     

    Approval was based on a Phase III trail showing that after 12 weeks of treatment, cyclosporine ophthalmic solution 0.09% showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production), compared with vehicle. Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after initiating treatment.

    The solution is dosed twice daily and will be available as a single-use vial.   

  • August 20, 2018

    FDA has approved a novel, extended-release formulation of methylphenidate for the treatment of ADHD in patients aged 6 years and older. It is taken once daily in the evening at 8:00, instead of immediately upon waking, to provide early-morning symptom control.

    Timing of administration may be adjusted between 6:30 p.m. and 9:30 p.m. to optimize the tolerability and the efficacy the next morning and throughout the day.

    Effectiveness of methylphenidate was established in two separate Pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled studies conducted in a total of 278 pediatric patients aged 6 to 12 years with a diagnosis of ADHD per DSM-5 criteria.

    In addition to the traditional scales that assess efficacy in ADHD clinical trials, such as the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale and the ADHD Rating Scale (ADHD-RS-IV), Ironshore’s pivotal trials assessed methylphenidate's efficacy in the early morning period using the morning subscale of the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) scale and the Before School Functioning Questionnaire (BSFQ).

    Ironshore plans to make the drug available commercially in the first half of 2019.

  • August 16, 2018

    FDA has approved segesterone acetate and ethinyl estradiol vaginal system under the trade name Annovera. The combined hormonal contraceptive is the first vaginal ring contraceptive that can be used for an entire year.

    Annovera is a reusable donut-shaped (ring), nonbiodegradable, flexible vaginal system that is placed in the vagina for 3 weeks, followed by 1 week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every 4 weeks for 1 year (thirteen 28-day menstrual cycles).

    The ring is washed and stored in a compact case for the 7 days not in use. It does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30° C (86° F).

    Efficacy and safety of Annovera were studied in three open-label clinical trials that included healthy women ranging in age from 18 to 40 years. The results showed that about 2 to 4 women out of 100 may get pregnant during the first year they use Annovera.

    Annovera carries a boxed warning on cigarette smoking and serious cardiovascular events. Women older than 35 who smoke should not use Annovera. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

    Annovera also is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic diseases; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the Annovera components; and use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

    The most common adverse effects are similar to those of other combined hormonal contraceptive products, such as headache/migraine, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, diarrhea, and genital itching.

    FDA is requiring postmarketing studies to further evaluate the risks of venous thromboembolism and the effects of CYP3A-modulating drugs and tampon use on the pharmacokinetics of Annovera.

  • August 16, 2018

    FDA approved migalastat, the first oral medication for the treatment of adults with Fabry disease, a rare and serious genetic disorder caused by mutations in the alpha-galactosidase A (GLA) gene located on the X-chromosome. The disease results from buildup of globotriaosylceramide (GL-3) in blood vessels, the kidneys, the heart, the nerves, and other organs.

    It is estimated that classic Fabry disease (the most severe type) affects approximately one in 40,000 males. The later-onset type is more frequent and in some populations may occur in one in 1,500 to 4,000 males. Patients with Fabry disease develop slowly progressive kidney disease, cardiac hypertrophy, arrhythmias, stroke, and early death.

    Efficacy was demonstrated in a 6-month, placebo-controlled clinical trial in 45 adults with Fabry disease. Patients treated with migalastat had a greater reduction in GL-3 in blood vessels of the kidneys (as measured in kidney biopsy samples) compared with patients on placebo. Migalastat's safety was studied in four clinical trials that included 139 patients with Fabry disease.

    The most common adverse drug reactions were headache, nasal and throat irritation, urinary tract infection, nausea, and fever.