Schering-Plough's inhaled corticosteroid asthma therapy Asmanex (mometasone furoate) will be available to patients as young as 4 years starting in the second half, the company told "The Pink Sheet" DAILY.

Asmanex, a powdered formulation delivered via Schering's Twisthaler , is now approved for the maintenance treatment of asthma as a preventive therapy in patients 4-11 years old.

The recommended pediatric dose is 110 mcg (one puff) administered once daily in the evening. Asmanex Twisthaler is the only inhaled corticosteroid approved for once-daily dosing in children as young as 4 years, Schering said. It is indicated as a prophylactic therapy, not for the relief of acute bronchospasm.

Asmanex comes with a warning that orally inhaled corticosteroids may affect growth and that patients should be monitored and given the lowest effective dose to minimize risk. However, 52-week trial data comparing growth rates among children in the 110 mcg treatment group versus placebo showed no statistical difference, Schering told the DAILY.

The product was approved for patients 12 and older in March 2005 after seven years of back and forth with FDA that included an "approvable" letter related to good manufacturing practices. Mometasone also is marketed by Kenilworth, N.J.-based Schering in the nasal allergy inhaler Nasonex and in the topical cream Elocon .

Schering tested the inhaler in three, 12-week, placebo-controlled trials involving 630 patients 4-11 as well as in a 152-patient, 52-week active-controlled safety trial. All patients previously were maintained on bronchodilators and/or inhaled corticosteroids. According to the product's label, all of the trials supported efficacy in that population.

The label features one 12-week trial in which Asmanex Twisthaler was tested against placebo in 296 children. Patients given 110 mcg of Asmanex once daily in the evening showed a statistically significant improvement in lung function, scoring 4.73 as a group on the forced expiratory volume in one second (FEV1) scale compared with -1.77 for placebo.

Schering touts the convenience of the Twisthaler, which is driven by inhalation rather than a propellant and thus eliminates the complication of hand-breath coordination. The device also has a dose-counting feature that ticks down after each use and locks when the counter is at zero.

Following reports in late 2006 that the dose counter was malfunctioning, Schering made improvements (¹ Also see "Asmanex Inhaler Dosing Counter Issues Under Investigation By Schering" - Pink Sheet, 17 November, 2006.). Corrective actions, including reinforcing the lock-out mechanism, were completed in the third quarter of 2007, Schering told the DAILY.

In August 2006, Schering and Novartis agreed to develop a combination treatment for asthma and chronic obstructive pulmonary disease that pairs Asmanex with Novartis' beta2 antagonist indacaterol (² Also see "Schering/Novartis To Develop Once-Daily Inhalation Combination For Asthma, COPD" - Pink Sheet, 14 August, 2006.). The agreement still is in effect and development is ongoing, Schering said.

-Shirley Haley (s.haley@elsevier.com)

Schering-Plough’s Asmanex Twisthaler Gains Pediatric Indication

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