The US Food and Drug Administration (FDA) approved several drugs in July 2022 relevant to conditions often treated by nurse practitioners and PAs. Approvals include treatments for seizures, nonsegmental vitiligo, fecal incontinence, and ALK-positive inflammatory myofibroblastic tumor.
Zonisade™ for Seizures
The FDA has approved an oral version of Zonisade™ (zonisamide oral suspension) as adjunctive therapy for the treatment of partial-onset seizures in patients 16 years of age and older. This is the first FDA-approved oral liquid formulation of zonisamide.
The approval of Zonisadewas based on a bioavailability study that compared the efficacy of Zonisade oral suspension to zonisamide capsules in healthy individuals.
The most common adverse reactions include somnolence, anorexia, dizziness, ataxia, agitation/irritability, and difficulty with memory and/or concentration. Zonisade should be administered using an accurate measuring device and any unused portion should be discarded 30 days after opening.
Zonisade oral suspension contains 100 mg/5 mL of zonisamide as a strawberry-flavored liquid in a 150-mL bottle.
Xalkori® for Myofibroblastic Tumor
Xalkori® (crizotinib) has been approved by the FDA for treatment of unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumor (IMT) in patients 1 year of age and older.
The approval was based on data from 2 multicenter open-label trials that included 14 pediatric patients (NCT00939770) and 7 adult patients (NCT01121588). Pediatric patients received Xalkori 280 mg/m2 twice daily and adults received 250 mg twice daily.
Of the 14 pediatric patients, 12 (86%; 95% CI, 57-98) achieved an objective response; among the 12 patients who experienced a response, 7 maintained the response for at least 6 months and 7 maintained the response for at least 12 months.
Of the 7 adult patients, 5 achieved an objective response including 1 with a complete response. Five patients maintained the response for at least 6 months and 2 maintained the response for at least 12 months.
The most common adverse reactions reported in pediatric patients taking Xalkori include vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache. The most common adverse reactions reported in adult patients include vision disorders, nausea, and edema.
Opzelura™ for Nonsegmental Vitiligo
The FDA has approved Opzelura™ (ruxolitinib) cream for the treatment of nonsegmental vitiligo in patients 12 years of age and older. Opzelura is the first treatment to address repigmentation in patients with vitiligo.
Approval was based on data from the phase 3 TRuE-V1 and TRuE-V2 trials that evaluated the safety and efficacy of Opzelura in 674 participants diagnosed with nonsegmental vitiligo and had depigmented areas. Patients were randomly assigned 2:1 to receive either Opzelura or vehicle cream (placebo) twice daily for 24 weeks followed by an additional 28 weeks of treatment with Opzelura twice daily for all patients.
Results from both trials showed that 29.9% of patients treated with Opzelura achieved at least 75% improvement from baseline respectively at 24 weeks compared with 7.5% and 12.9% of patients given vehicle cream.
The most common adverse reactions include application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.
Opzelura is supplied in 60 g tubes containing 1.5% of ruxolitinib. Satisfactory response may require treatment for more than 24 weeks.
leva® Pelvic Health System for Fecal Incontinence
The leva® Pelvic Health System has been approved by the FDA for first-line treatment of chronic fecal incontinence in women. The device is a noninvasive digital therapeutic intended for rehabilitation and training of weak pelvic floor muscles at home.
Approval is based on data from a single-arm, open-label, 10-week pilot study that included 29 participants with fecal incontinence. Findings indicated that use of the device resulted in significant improvement in the severity of fecal incontinence symptoms among 27 participants.
The system includes a vaginal wand embedded with motion sensors, connector, and transmitter box. The wand is inserted into the vagina, after which patients can download the leva app and begin training. Each training session can be completed in 2.5 minutes twice daily for a total of less than 5 minutes a day.
The Ieva Pelvic Health System is available by prescription only and is compatible with both iOS and Android smartphones.
1. Zonisade. Prescribing information. Azurity Pharmaceuticals, Inc.; 2022. Accessed July 26, 2022. https://azurity.com/wp-content/uploads/2022/07/ZONISADE-Prescribing-Information-rev-07.22.pdf
2. Xalkori. Prescribing information. Pfizer In.; 2022. Accessed July 26, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202570s033lbl.pdf
3. Opzelura. Prescribing information. Incyte; 2022. Accessed July 26, 2022. https://www.opzelura.com/prescribing-information.pdf
4. Ieva Pelvic Health System: Instructions for Use. Renovia; 2022. Accessed July 7, 2022. https://www.levatherapy.com/files/leva-Instructions-For-Use.pdf