The Food and Drug Administration (FDA) approved several drugs in August and September relevant to conditions practiced by nurse practitioners and PAs. These approvals include treatments for migraines, tick-borne encephalitis, idiopathic hypersomnia, and plaque psoriasis.
August
Vagus Nerve Stimulation System for Stroke Rehabilitation Therapy
The MicroTransponder Vivistim Paired VNS System (Vivistim System) was approved by the FDA to treat moderate to severe extremity motor deficits associated with chronic ischemic stroke through vagus nerve stimulation (VNS).
The Viivstim System consists of an implantable pulse generator (IPG) that is placed under the patient’s skin and generates a mild electrical pulse. The system also includes clinician software that is preloaded onto a laptop and wireless transmitter to be used only by a health care provider. Clinicians can adjust IPG settings (eg, amplitude, frequency, and pulse width) and record stimulation history.
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Approval was based on a controlled study conducted in 108 patients with moderate to severe arm weakness at least 9 months after an ischemic stroke. Patients in the treatment group had an average 5-point increase in Upper Extremity Fugl-Meyer Assessment (FMA-UE) score after 6 weeks of therapy compared with a 2.4-point increase in the control group.
Adverse reactions included dysphonia, bruising, falling, general hoarseness, general pain, hoarseness after surgery, low mood, muscle pain, fracture, headache, rash, dizziness, throat irritation, urinary tract infection, and fatigue.
The Vivistim is a prescription device may be used at home use or in clinical settings.
TicoVac for Tick-Borne Encephalitis
TicoVacTM was approved by the FDA for active immunization of tick-borne encephalitis (TBE) in persons 1 year and older. The agent is intended for use in patients visiting or living in TBE endemic areas.
Approval was based on data from clinical trials that assessed the safety and immunogenicity of the vaccine across 2 age groups (1 to 15 years and 16 to 65 years).
The vaccine is administered in a series of 3 doses; 0.25 mL for ages 1 to 15 and 0.5 mL for those 16 years and older. TicoVac is available in prefilled syringes in 1-count and 10-count cartons.
Skyrizi Single-Dose Injection for Plaque Psoriasis
Skyrizi® (risankizumab-rzaa) is now available as a single-dose, 150-mg prefilled pen or syringe to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The new injection features an inspection window, cues to indicate the beginning and end of the administration process, and signal to indicate when administration is complete.
Patients can self-inject after training in subcutaneous injection technique.
Xywav for Idiopathic Hypersomnia
The FDA approved Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution for treatment of idiopathic hypersomnia in adults.
Approval was based on a controlled study that assessed efficacy and safety in patients with idiopathic hypersomnia and the most common adverse reactions included nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.
Xywav, a Schedule III controlled substance, carries a Boxed Warning regarding central nervous system (CNS) depression and the potential for abuse and misuse. The product is only available through a restricted distribution program and is supplied as 0.5 g/mL total salts in 180 mL bottles.
September
Keytruda for Urothelial Carcinoma
Keytruda® (pembrolizumab) was granted full approval by the FDA and a revised indication for the treatment of patients who have locally advanced or metastatic urothelial carcinoma (mUC) and are not eligible for platinum-containing chemotherapy or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Approval was based on a trial that assessed safety and efficacy of pembrolizumab as monotherapy and in addition to chemotherapy in 1010 patients with locally advanced or mUC.
Keytruda is also indicated for treatment in patients with locally advanced or mUC who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Trudhesa Nasal Spray for Migraines
The FDA approved Trudhesa™ (dihydroergotamine mesylate) nasal spray for acute treatment of migraines in adults. Proprietary technology is used to deliver a low dose (0.725 mg per spray) of dihydroergotamine mesylate to the upper nasal space.
Approval was based on data from a phase 3 study that assessed safety and tolerability in 354 adults who had a documented diagnosis of migraine with or without aura.
The most common adverse reactions reported were rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea. Trudhesa is supplied in a package of 4 single-dose units (4 mg each) and 1 nasal spray device. The recommended dose is 1.45 mg administered as 2 metered sprays into the nose (1 spray of 0.725 mg into each nostril).
Trudhesa is expected to be available in early October 2021.
Invega Hafyera for Schizophrenia
The FDA approved Invega Hafyera™ (paliperidone palmitate), a twice-yearly, gluteal intramuscular injection for adults with schizophrenia.
Approval was based on a 12-month study that compared efficacy and safety in 702 adults diagnosed with schizophrenia who were previously stabilized on corresponding doses of Invega Sustenna or Invega Trinza.
The safety profile of Invega Hafyera resembled the safety seen in previous studies with Invega drugs.
The most common adverse reactions include upper respiratory tract infection, injection site reaction, increased weight, headache, and parkinsonism. Invega Hafyera is supplied as 1092 mg/3.5 mL and 1560 mg/5 mL paliperidone palmitate in a kit containing a single-dose prefilled syringe and safety needles.
Opzelura for Atopic Dermatitis
OpzeluraTM (ruxolitinib) cream was approved for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in nonimmunocompromised patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Approval was based on data from a clinical trial that assessed safety and efficacy of Opzelura in more than 1200 patients 12 years and older with atopic dermatitis.
Opzelura is supplied in 60 g tubes and carries a Boxed Warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis associated with the use of JAK inhibitors for inflammatory conditions.
Most common adverse reactions include ear infection, bronchitis, diarrhea, eosinophil count increased, urticaria, folliculitis, tonsillitis, and nasopharyngitis.
References
TicoVac. Prescribing information. Pfizer; 2021. Accessed September 28, 2021. http://labeling.pfizer.com/ShowLabeling.aspx?id=15600
Skyrizi. Prescribing information. Rxabbvie; 2021. Accessed September 28, 2021. https://www.rxabbvie.com/pdf/skyrizi_pi.pdf
Xywav. Prescribing information. Jazz Pharmaceuticals; 2021. Accessed September 28, 2021. https://pp.jazzpharma.com/pi/xywav.en.USPI.pdf
Keytruda. Prescribing information. Merck; 2021. Accessed September 28, 2021. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
Trudhesa. Prescribing information. Impel; 2021. Accessed September 28, 2021. https://www.trudhesa.com/trudhesa-prescribing-information.pdf
Invega Hafyera. Prescribing information. Janssen; 2021. Accessed September 28, 2021. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVEGA+HAFYERA-pi.pdf
Opzelura. Prescribing information. Accessed September 28, 2021. https://www.opzelura.com/prescribing-information.pdf
