The US Food and Drug Administration (FDA) approved several drugs in October relevant to conditions treated by nurse practitioners and PAs. These approvals include treatments for acute pain, dry eye disease, opioid overdose, and COVID-19 vaccine for children 5 to 11 years of age.
Seglentis® for Acute Pain
The FDA has approved Seglentis®, a combination of celecoxib and tramadol hydrochloride, for the management of acute pain in adults that is severe enough to require an opioid and for which alternative treatments are inadequate.
The approval was based on findings from a phase 3 randomized trial that evaluated the safety and efficacy in 637 patients 18 years and older with acute postoperative pain after unilateral first metatarsal osteotomy with internal fixation.
Results indicated that patients taking Seglentis showed greater improvement in summed pain intensity difference over 48 hours (SPID48) scores compared with patients in other treatment arms.
The most common adverse reactions include nausea, vomiting, dizziness, headache, and somnolence. Seglentis is supplied as coated tablets containing 56 mg of celecoxib and 44 mg of tramadol hydrochloride in 30- and 90-count bottles. Seglentis is expected to be available in early 2022.
COVID-19 Vaccine for Children
Pfizer-BioNTech COVID-19 vaccine, Comirnaty®, was approved for children aged 5 to 11 years by the FDA’s Vaccines and Related Biological Products Advisory Committee. This approval was based on data from a phase 2/3 study including 2268 participants who received a 2-dose regimen of 10 mcg administered 3 weeks apart. The 10 mcg dose produced strong antibody responses similar to those found with the 30 mcg dose given to individuals 16 to 25 years of age.
The vaccine efficacy at 7 days after the second dose was 90.7%. Three cases of COVID-19 occurred in the vaccine group vs 16 cases in the placebo group during the follow-up period.
The most commonly reported solicited adverse reactions were pain at the injection site, fatigue, and headache; lymphadenopathy was the most frequently reported unsolicited adverse event.
Study results related to children younger than 5 years and a 2-dose series of 3 mcg are expected later this year.
Zimhi™ for Opioid Overdose
Zimhi™ (naloxone hydrochloride) injection was approved by the FDA for emergency treatment of known or suspected opioid overdose. This opioid antagonist is supplied in a single-dose, prefilled syringe that delivers 5 mg/0.5 mL naloxone hydrochloride solution for intramuscular or subcutaneous use.
Approval was based on pharmacokinetic study of 14 healthy adults in which a single intramuscular injection of 5 mg provided significantly higher Cmax and AUC compared with a single intramuscular injection of naloxone HCl 2 mg.
Zimhi is expected to be available in early 2022.
Tyrvaya™ for Dry Eye Disease
Tyrvaya™ (varenicline solution) nasal spray was approved by the FDA for the treatment of dry eye disease. Tyrvaya stimulates natural tear film production by activating the trigeminal parasympathetic pathway in the nasal cavity. The bottle delivers a 0.05 mL spray containing 0.03 mg of varenicline.
The approval was based on data from the phase 3 ONSET-2, phase 2b ONSET-1, and phase 2 MYSTIC trials that included over 1000 patients with mild to moderate dry eye disease.
The most common adverse reactions reported include sneezing, coughing, throat irritation, and nose irritation.
Tyrvaya is supplied in a carton containing 2 nasal spray bottles containing 60 sprays per bottle. The recommended dosage is 1 spray into each nostril twice daily.
1. Seglentis. Prescribing information. Kowa Pharma; 2021. Accessed November 5, 2021. https://www.kowapharma.com/documents/SEGLENTIS_Prescribing_Information.pdf
2. FDA Briefing Document. EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age. October 26, 2021. Accessed November 5, 2021. https://www.fda.gov/media/153447/download.
3. Zimhi. Prescribing information. Adamis; 2021. Accessed November 5, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212854s000lbl.pdf
4. Tyrvaya. Prescribing information. Oyster Point Pharma; 2021. Accessed November 5, 2021. https://www.tyrvaya-pro.com/files/prescribing-information.pdf