FDA approved Dey's Perforomist (formoterol fumarate) 20 mcg/2mL inhalation solution for the long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, the company announced May 11.

The approval marks the first nebulized version of formoterol, a long-lasting beta2 agonist already available in a dry powder version for inhalation. The approval was cleared by FDA through the 505(b)2 pathway.

Novartis markets Foradil Certihaler , which delivers 10 mcg of formoterol via inhalation with dosing every 12 hours, and also licenses U.S. marketing rights to Schering-Plough for Foradil Aerolizer , which delivers 12 mcg of formoterol via inhalation whereby the patient inserts a capsule into the device before inhalation.

In comparison, Perforomist is taken by a nebulizer, which converts liquid medicines into a mist that patients can inhale through a mouthpiece or face mask, the subsidiary of Germany's Merck KgaA explained.

In April, FDA issued a tentative approval for Perforomist, based on a Paragraph IV certification through the 505(b)(2) pathway for the U.S. Patent No. 6,488,027, owned by Novartis and related to Foradil. According to FDA's "Orange Book" the Foradil patent is valid until March 8, 2019.

However, Dey told "The Pink Sheet" DAILY that Novartis opted not to file a patent infringement suit. If the company had filed suit, it would have initiated a 30-month stay of approval.

Dey said it plans to launch the formula "reasonably soon." The company will detail the drug through its existing 200-person sales force and will also supplement the force with a smaller number of reps from Critical Therapeutics through a copromotion agreement.

Critical Therapeutics and Dey are also partnered on the promotion of Critical Therapeutics' asthma drug Zyflo (zileuton).

"Because nebulization is an easy, effective and thorough method of delivering medicine directly into the lungs, many COPD patients prefer it, particularly as they become increasingly frail due to their disease progression," the Napa, Calif., company said.

FDA approval was based on two clinical trials involving 1,045 patients. A 12-week, Phase III study of 351 patients compared the safety and efficacy of Perforomist 20 mcg/2mL twice daily to Foradil or placebo. The study results showed that Perforomist was statistically superior to placebo for the primary endpoint, forced expiratory volume in one second and area under curve for forced expiratory volume. The safety and efficacy of Perforomist was similar to Foradil.

The drug includes similar warnings as other long-acting beta agonists regarding the increased risk of asthma-related death.

In 2005, FDA issued a public health advisory stating that LABA bronchodilators such as GlaxoSmithKline's Serevent (salmeterol) and Advair (salmeterol/fluticasone) and Foradil should be used as a second-line treatment for asthma patients due to a potential for asthma related deaths (¹ Also see "Serevent, Advair, Foradil Relegated To Second-Line For Asthma Patients" - Pink Sheet, 18 November, 2005.).

GSK, Theravance, Schering-Plough and Novartis are currently collaborating on a development program called Beyond Advair, seeking to develop the first once-daily LABA and corticosteroid combination (² Also see "GSK/Theravance Target 2008 Phase III Start For Next-Gen Bronchodilators" - Pink Sheet, 3 April, 2007.).

Labeling for Perforomist says it should not be used with other medications containing LABAs and advises patients not to "nebule" more than once, twice daily. The safety and efficacy of Perforomist in asthma has not been established, labeling says.

- Jessica Merrill (j.merrill@elsevier.com)

Dey Perforomist Inhalation Solution Clears FDA for Bronchoconstriction In COPD

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