Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%

Allergan plc  announced that the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, has been accepted by the U.S. Food and Drug Administration (FDA) for standard review. Allergan expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of 2017.

"While rosacea is a common chronic skin condition that affects more than 16 million people in the U.S. alone1, there is a significant unmet need in effective, FDA-approved treatments for the condition," said David Nicholson, Chief R&D Officer, Allergan. "The NDA filing of oxymetazoline speaks to our strong commitment to ongoing innovation of our medical dermatology portfolio, and we look forward to bringing a new treatment option to patients with rosacea."

About Oxymetazoline

Oxymetazoline is a sympathomimetic agonist that is selective for the α1A-adrenoceptor over other α1-adrenoceptors and non-selective for the α2-adrenoceptors. As such, oxymetazoline is a potent vasoconstrictor of the cutaneous microvasculature. The NDA submission for oxymetazoline HCL cream 1.0% was based on data collected from two phase 3 pivotal clinical trials of a 29-day treatment duration and a 1-year open label clinical trial. These studies enrolled male and female patients ≥ 18 years of age with moderate to severe persistent facial erythema associated with rosacea.

Sustained use of oxymetazoline cream efficacious for rosacea

In continuation of my update on oxymetazoline

Zoe Diana Draelos, M.D., from Dermatology Consulting Services in High Point, Tenn., and colleagues examined the long-term safety (one year) and efficacy of oxymetazoline cream 1.0 percent in 440 patients with rosacea with moderate-to-severe persistent facial erythema. Assessments were conducted at three and six hours after the dose on day one, and at weeks four, 26, and 52.

The researchers found that 8.2 percent of patients reported treatment-emergent adverse events (TEAEs), the most common were application site dermatitis, paresthesia, pain, and pruritus. The rate of discontinuation mostly due to application-site TEAEs was 3.2 percent. There was no clinically meaningful skin blanching, inflammatory lesions, or telangiectasia. At week 52, a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment three and six hours after a dose was seen in 36.7 and 43.4 percent of patients, respectively. Following treatment cessation, less than 1 percent of patients experienced a rebound effect.

"This long-term study demonstrated sustained safety, tolerability, and efficacy of oxymetazoline for moderate-to-severe persistent erythema of rosacea," the authors write.Zoe Diana Draelos, M.D., from Dermatology Consulting Services in High Point, Tenn., and colleagues examined the long-term safety (one year) and efficacy of oxymetazoline cream 1.0 percent in 440 patients with rosacea with moderate-to-severe persistent facial erythema. Assessments were conducted at three and six hours after the dose on day one, and at weeks four, 26, and 52.

The researchers found that 8.2 percent of patients reported treatment-emergent adverse events (TEAEs), the most common were application site dermatitis, paresthesia, pain, and pruritus. The rate of discontinuation mostly due to application-site TEAEs was 3.2 percent. There was no clinically meaningful skin blanching, inflammatory lesions, or telangiectasia. At week 52, a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment three and six hours after a dose was seen in 36.7 and 43.4 percent of patients, respectively. Following treatment cessation, less than 1 percent of patients experienced a rebound effect.

"This long-term study demonstrated sustained safety, tolerability, and efficacy of oxymetazoline for moderate-to-severe persistent erythema of rosacea," the authors write.

St. Renatus, LLC Announces FDA Approval of Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray for Use in Dentistry

St. Renatus, LLC, a privately held company based in Fort Collins, Colorado,  announced the U.S. Food and Drug Administration (FDA) approval on June 29, 2016 for its first product, a new dental anesthetic, Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray. This is the first product that allows for dental anesthesia to be administered through a nasal spray without using a needle.

 Tetracaine           Oxymetazoline

"For more than 100 years, the dental industry has delivered dental anesthesia using a needle injection. Now, through the efforts of a dedicated team, we have developed a revolutionary needle-free method for delivering pulpal anesthesia," said Steve Merrick, St. Renatus' CEO.

Kovanaze is intended for use in dentistry as a topical anesthetic, delivered in the nasal cavity to achieve pulpal (tooth nerve) anesthesia for the restorative treatment of teeth. Like traditional dental injections, this product delivers a local dental anesthetic but without the needle.

Kovanaze is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.