Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ORTHO RETIN-A .05% NDA FOR PHOTOAGING CLAIM

Executive Summary

ORTHO RETIN-A .05% NDA FOR PHOTOAGING CLAIM was filed in July. Johnson & Johnson subsidiary Ortho Pharmaceutical submitted the NDA for a .05% cream formulation of the topical prescription product tretinoin based on efficacy studies in 650 patients. The studies, conducted at nine centers, followed patients for six months and tracked Retin-A's efficacy in reducing the signs of photoaging damage due to sun exposure, such as wrinkling, blotching and loss of elasticity. The NDA focuses on a mid-level concentration of the acne drug. Retin-A was originally approved for acne at a 0.1% concentration; a milder, 0.25% version was approved in September 1988. Ortho has a .05% gel form of Retin-A in addition to the cream. Ortho said it is "looking for successor compounds to Retin-A which are equally effective" but less irritating in the treatment of photoaged skin. Researchers are also examining the drug's potential in other areas such as preventing the progression of actinic keritoses -- premalignant growths -- into skin cancer. Ortho's photaging NDA filing comes nearly two years after Retin-A began to receive substantial consumer interest for its potential as an anti-wrinkling therapy. Pharmacy sales for Retin-A in 1988 more than doubled following widespread publicity on the drug's efficacy as an anti-wrinkling agent. Sales jumped 127% to $ 63.8 mil. for the year, according to the audit service firm Pharmaceutical Data Systems ("The Pink Sheet" March 20, T&G-6). Retin-A's potential as a photoaging treatment was discussed at an April 1986 Boston University Medical Center seminar. In a 1988 press conference, University of Michigan Medical Center dermatologist John Voorhees, MD, presented results of a four-month 30-patient study sponsored by Ortho on the effect of Retin-A as a photoaging treatment. The study was published in the Jan. 22/29, 1988 Journal of the American Medical Association. A National Institutes of Health panel concluded in May that available data on tretinoin did not demonstrate "sustained improvement, reversibility of tissue pathology, or the preservation of normal skin function by those agents." In addition, the panel noted that no long-term data exists regarding repeated application toxicity ("The Pink Sheet" May 15, p. 16).

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

RS150923

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel