FDA Update for the Week of July 24, 2023

FDA Approves Second Nonprescription Naloxone Nasal Spray.

The FDA has approved Harm Reduction Therapeutics’ nonprescription RiVive (naloxone) 3.0 mg nasal spray for the emergency treatment of opioid overdose. RiVive will be made available for free or low cost, and company executives said in a press release that no company will profit from the product.

Harm Reduction Therapeutics said it will supply RiVive to communities that need it most and will make at least 200,000 doses (10% of projected initial annual product production) available for free. ReVive, which is delivered as an atomized spray (0.1 ml) using a standard unit dose system for single administration, is expected to be available in early 2024.

Drug overdose continues to be a major public health issue in the United States. In the 12-month period ending in February 2023, more than 105,000 reported fatal overdoses occurred which were primarily driven by synthetic opioids like illicit fentanyl, according to the FDA. And since 2017, more than 290,000 people across the United States have died of an opioid overdose, according to the National Institute on Drug Abuse.

FDA Approves First Drug for Skin Infection from Pox Virus.

The FDA has approved Ycanth (cantharidin) for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older as an in-office administered therapy. Developed by Verrica Pharmaceuticals, Ycanth (perviously VP-102) is the first FDA-approved treatment for molluscum, a highly contagious viral skin infection affecting about 6 million people annually in the United States. Molluscum is caused by a pox virus that produces raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection.

Ycanth is a drug-device combination product that contains cantharidin (0.7% w/v) delivered via a single-use applicator. It will be available by September 2023. The company has not yet released information on pricing.

At a presentation for investors, company officials indicated that payers recognize the unmet need in treating molluscum. Payers in both commercial and Medicaid markets — representing more than 205 million lives — have indicated they will provide coverage on the medical benefit side. Minimal rebates will be required, company officials said.

FDA Approves Xdemvy for Eye Infection Caused by Mites.

The FDA has approved Xdemvy (lotilaner) to treat patients with Demodex blepharitis. Developed by Tarsus Pharmaceuticals, Xdemvy is the first FDA approved treatment to directly target inflammation that is caused by Demodex mites.

Blepharitis is a common disease of the eyelid that causes inflammation, redness and eye irritation. Demodex mites — parasites that mostly live in hair follicles and oil glands on the face, neck, or chest — can cause blepharitis. Demodex blepharitis impacts about 25 million eye care patients in the United States.

Xdemvy is an eye drop that is designed to eradicate the Demodex mites, which are too small to see with the naked eye. It is given as a single drop in each eye twice daily for six weeks. Xdemvy will be available by the end of August 2023 and will have a wholesale acquisition cost of $1,850 per prescription, the company said at an investor meeting. Executives said the pricing reflects the value the therapy provides.

FDA Accepts sNDA for Ofev in Children with Rare Lung Disease.

The FDA has accepted Boehringer Ingelheim’s supplemental new drug application (sNDA) for Ofev (nintedanib), to treat children and adolescents between 6 to 17 years old with fibrosing interstitial lung disease (ILD). A decision is expected in the fourth quarter of this year.

Interstitial lung disease is rare condition that includes more than 200 disorders, with about 30 disorders that effect children. There are less than 10,000 estimated cases in the United States in children, according to the Children’s Interstitial Lung Disease Foundation. Pulmonary fibrosis is a lung disease that occurs when lung tissue becomes damaged and scarred, making it difficult to breath.

Ofev is a tyrosine kinase inhibitor that works by inhibiting pathways involved in pulmonary fibrosis. It is currently approved to treat adults with idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung disease and interstitial lung disease associated with systemic sclerosis.

The cost is about $12,496 for a supply of 60 capsules. A spokesperson said the price is similar to other therapies for rare/orphan diseases approved by the FDA. Boehringer Ingelheim offers a number of programs designed to support patients, including copay assistance for eligible patients and a patient support program.

For the children's indication, dosing would be weight-based, and the spokesperson would not comment on the price for a children's dose.