Nasacort AQ Switch Rides On “Evolution Of Data” – Sanofi CMO

Charles Hugh-Jones, Sanofi’s chief medical officer for North America, says the firm will present clinical and consumer use data to allay concerns about the safety of intranasal corticosteroids, at the upcoming FDA advisory committee meeting to discuss the Rx-to-OTC switch of Nasacort AQ.

Sanofi believes its totality of clinical and consumer use data will convince FDA’s Nonprescription Drugs Advisory Committee on July 31 that the time is right for the firm’s Nasacort AQ intranasal corticosteroid to switch OTC.

Charles Hugh-Jones, the firm’s chief medical officer for North America, explained that currently available OTC decongestants and antihistamines do not comprehensively treat the runny nose, sneezing, itching and nasal congestion symptoms that accompany allergic rhinitis, while intranasal corticosteroids do.

Sanofi filed a supplemental new drug application in late 2012 asking FDA for a first-in-class Rx-to-OTC switch of Nasacort AQ (triamcinolone acetonide), to be indicated for temporary relief of hay fever and other upper respiratory allergies (Also see "Sanofi’s Nasacort AQ Rx-To-OTC Switch Under FDA Review" - Pink Sheet, 24 Jun, 2013.).

A joint task force organized in part by the American College of Allergy, Asthma & Immunology recommended in 2006 against the switch of intranasal corticosteroids such as Nasacort AQ, given the potential for overuse and long-term side effects.

Sanofi, however, now has the efficacy and safety data to respond to those concerns and support a switch of the nasal spray, Hugh-Jones said.

Charles Hugh-Jones

Photo courtesy of Sanofi

Sanofi has 16 years of U.S. safety data for Nasacort AQ in Rx form, and Hugh-Jones pointed out the drug already is available without a prescription in 11 markets, including the U.K., Australia, New Zealand, Denmark and Norway.

“With the evolution of data over the last few years, we feel that it is the right time to bring it over the counter and to provide that sort of access to the people who really are suffering from what is a fairly unpleasant condition,” he said in an interview.

Sanofi has sponsored a number of trials on Nasacort AQ in recent years, according to the National Institutes of Health’s ClinicalTrials.gov website. In 2012, Sanofi completed a study on the drug’s effects on the growth of children aged 3 to 9 years suffering from perennial allergic rhinitis.

Another study, the results of which the French company reported in 2007, found Nasacort AQ did not cause significant adrenal suppression over a six-month period in children aged 2 to 5 years with allergic rhinitis. The drug, in both Rx and proposed OTC versions, is indicated for use in adults and children aged 2 and older.

The ACAAI task force in 2006 raised concerns about growth suppression, loss of bone substance and elevated glaucoma risk associated with intranasal corticosteroids.

Hugh-Jones says safety data generated over the past seven years will address many of those concerns, but in 2012 Teva Respiratory LLC came out against the OTC switch of intranasal corticosteroids, citing the possibility of allergic rhinitis masking undiagnosed asthma. Teva markets Rx treatments for allergic rhinitis such as QNASL (beclomethasone dipropionate) and has an interest in keeping OTC competition off the market.

NDAC: Help Wanted

FDA likely scrambled to fill the advisory committee roster for the July 31 meeting in Silver Spring, Md., given that NDAC currently has just three standing members, one of whom is non-voting, and 12 vacancies.

NDAC Chairman Richard Neill, of the University of Pennsylvania, and member Ruth Parker, of Emory University, both are old hands at Rx-to-OTC switch and their terms on the committee run through May 2014. The non-voting industry representative, consultant Lorna Totman, has a seat through October 2015.

The terms of four other NDAC members expired on May 31, 2013: Neil Farber, University of California, San Diego; Walid Gellad, University of Pittsburgh; consumer representative Norma Martinez Rogers, University of Texas Health Science Center at San Antonio; and Marcus Reidenberg, Weill Cornell Medical College, who substituted for Neill as committee chairman at the most recent meeting of NDAC, which discussed the proposed switch of the Oxytrol for Women overactive bladder drug in November 2012 (Also see "NDAC Puts Hitch In Oxytrol Switch With Negative Self-Selection Vote" - Pink Sheet, 12 Nov, 2012.).

For the Oxytrol meeting, FDA filled NDAC’s vacancies with five subject matter experts – four urologists and a gynecologist, specifically – and one committee veteran. The agency likely employed a similar tack in recruiting advisors for the Nasacort AQ discussion and possible vote.

FDA plans to post the NDAC roster and other meeting materials online July 29.

[Visit www.TheTanSheet.com the week of July 29 for updates on the Nasacort AQ advisory committee meeting. And be sure to read the Aug. 5 issue of “The Tan Sheet” for full coverage of the meeting.]