In July 2021, several drugs have been approved by the Food and Drug Administration (FDA) that are of importance to nurse practitioners (NPs) and PAs. The approvals include treatments for type 2 diabetes (T2D) in adolescents, trichomoniasis, and acne vulgaris, as well as a vaccine for pneumococcal diseases.
Bydureon BCise for Type 2 Diabetes in Adolescents
Bydureon BCise® (exenatide extended-release) is now approved for adolescents 10 years and older diagnosed with T2D.1 Bydureon BCise is an injection to be used in conjunction with diet and exercise to improve glycemic control. The treatment was previously approved for use in adults only.
The approval is based on a double-blind phase 3 study that evaluated the safety and efficacy of the agent in 82 patients aged 10 to 17 years with T2D. The safety profile of this drug was similar to that in the adult population. Adverse reactions include injection site reactions, headaches, and gastrointestinal issues. The prescribing information contains a boxed warning of an increased risk of thyroid C-cell tumors in animal studies. Bydureon BCise is available as a prefilled injection containing 2 mg in a 4-count carton.
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Solosec for Trichomoniasis
Solosec® (secnidazole) has been approved for the treatment of trichomoniasis caused by Trichomonas vaginalis in adults.2 Solosec is a nitroimidazole antimicrobial agent that previously had only been approved for bacterial vaginosis.
The approval was based on data from a double-blind, placebo-controlled study that evaluated the safety and efficacy in 147 women diagnosed with trichomoniasis. Additionally, treatment was approved in men based on 4 open-label trials and 3 single-arm studies (in men and women). The most common adverse reaction reported during the trials was vulvovaginal candidiasis.
The recommended dosage of Solosec is a single 2-g packet taken orally. Trichomoniasis is a sexually transmitted disease, therefore sexual partners should be treated with the same dose at the same time.
Twyneo for Acne Vulgaris
Twyneo® is a fixed-dose combination of tretinoin (0.1%) and benzoyl peroxide (3%) in the form of a topical cream approved for the treatment acne vulgaris in patients 9 years and older.3
Twyneo was approved based on data from 2 phase 3 trials that evaluated safety and efficacy in 858 patients 9 years and older with moderate to severe acne. Adverse reactions appeared at the application site and included pain, dryness, exfoliation, erythema, dermatitis, pruritus, and irritation. Twyneo is available in a 50-g bottle.
Vaxneuvance for Pneumococcal Diseases
Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine) has been approved for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in adult patients 18 years and older.4 Vaxneuvance consists of pneumococcal polysaccharides from 15 stereotypes and approval was based on 7 studies that assessed Vaxneuvance in healthy adults and those at risk of pneumococcal diseases.
In clinical trials, the drug was regarded as generally well tolerated and adverse reactions included injection site pain/swelling/erythema, fatigue, myalgia, headache, and arthralgia. Vaxeunvance is supplied in single-dose, prefilled syringes containing 0.5-mL suspension for intramuscular injection.
References
1. Bydureon BCise. Prescribing information. Azpicentral; 2021. Accessed August 19, 2021. https://www.azpicentral.com/bydureon_bcise/bydureon_bcise.pdf#page=1
2. Solosec. Prescribing information. Solosec; 2021. Accessed August 19, 2021. https://www.solosec.com/pdfs/solosec-pi-2021.pdf
3. Twyneo. Prescribing information. Sol-Gel; 2021. Accessed August 19, 2021. https://www.sol-gel.com/downloads/twyneo-prescribing-information.pdf
4. Vaxneuvance. Prescribing information. Merck; 2021. Accessed August 19, 2021. https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_pi.pdf
