FDA approves new inhalable COPD treatment
chronic obstructive pulmonary disease (COPD) has been given the go
ahead by the US Food and Drug Administration (FDA).
The new formulation, manufactured by pharma firm Dey under the name Perforomist, is indicated for maintenance treatment of emphysema and chronic bronchitis, and according to the company offers a more user-friendly and convenient drug delivery option to COPD patients. Perforomist is the first and only FDA-approved nebulised formoterol fumarate, and is a rapid, long-lasting beta2 agonist that already has US approval in dry powder form. This new formulation of the compound will be converted from liquid form to a fine mist through a standard jet nebuliser, and then inhaled by patients through a mouthpiece or facemask. Due to be launched commercially in the fall of 2007, the company believes the Perforomist product offers a new and potentially more attractive treatment option for patients suffering with COPD. "By nebulizing with Perforomist inhalation solution twice a day…many COPD patients can achieve better control of their disease symptoms," said Nicholas Gross, principal investigator involved in the clinical evaluations of the new formulation. "The convenience of such simple dosing combined with a drug delivery option favored by many patients may provide improved symptom control and a better quality of life." Bronchodilators like formoterol are one of the most commonly prescribed classes of drugs for treatment of COPD. Most effective when inhaled, these drugs tend to be administered either via a nebulizer, metered-dose inhaler (MDI) or dry powder inhaler (DPI). MDIs and DPIs, however, need coordination and require the user to be able to hold a deep breath, not always an easy task for the elderly or those with advanced COPD. Nebulization, however, does not have these conditions, and is considered one of the easiest and most effective ways of administering COPD treatments. "Because nebulization is an especially gentle and thorough way to deliver medication into the lungs, and because it requires no special technique, coordination, or deeply held long breaths, many patients prefer it to inhaling dry powder drug formulations," a spokesperson for Dey explained to US-PharmaTechnologist.com. A further point in the nebulized formulation's favor lies in the fact that more of the therapeutic drug actually reaches the airways through nebulization, whereas MDIs and DPIs can lose a significant amount of medication on the way, sticking in the patient's throat and not reaching the lungs. Although currently unable to disclose any detailed pricing plans for nebulized Perforomist, Dey's spokesperson said that the company "prices its branded products in line with other patented therapies" used to treat COPD. The COPD market is currently worth around $2bn in sales, but estimates have suggested the market could grow to almost $9bn by 2010. In its evaluations of Perforomist, Dey compared the treatment with Novartis' inhalable product Foradil (formoterol fumarate inhalation powder), and found it to be just as effective as this powder formulation in treating COPD. Foradil generated net sales of $14m for Novartis during 2006 in the US alone, and a further $317m from outside the States. With its apparent advantages in terms of convenience and ease of use and at a cost comparable to other inhalable bronchodilators currently available, Dey's Perforomist could be expected to perform on a par with the Novartis drug, though Dey was unwilling to release any market performance projections for the product.
