Cellegy treatments for ED and anal fissures

Cellegy Pharmaceuticals has been issued a patent entitled: 'Combination Therapy for Treatment of Erectile Dysfunction.'

This patent delineates methods of decreasing the pain associated with the use of topical and injectable prostaglandins for treatment of erectile dysfunction by administering a prostaglandin and a low dose of a nitric oxide (NO) releasing agent such as nitroglycerin or isosorbide dinitrate.

Approximately two-thirds of current ED patients respond, at least temporarily, to treatment with oral type V phosphodiesterase (PDE) inhibitors, but and estimated 5-6m patients do not respond or cease to respond to them, and they are candidates for treatment with injectable prostaglandin E1 (PGE1; also known as alprostadil) sterile power for injection products such as Caverject (Pfizer/Pharmacia) and Edex (Schwarz Pharma) or other more invasive means.

Injectable PGE1 products are preferred by some patients due to their quick onset of action but while they are highly effective, the injectable products have not met with great popularity due to an approximately 40% incidence of PGE1 related penile pain experienced during or after injection.

Cellegy believes that its invention could significantly reduce or possibly eliminate the pain and irritation produced by injectable and topical prostaglandin products. According to Dr Vivien Mak, Cellegy's vice president of research: 'the increase of cyclic GMP produced by low dose NO releasing agents could attenuate local nerve fibre hypersensitivity and thus pain sensation induced by PGE1, without causing any additional untoward effects. Additionally, the combination of PGE1 and low dose NO releasing agents for the treatment of ED is therapeutically synergistic.'

Michael Forrest, CEO of Cellegy, commented:'Alprostadil (PGE1) is one of the most effective treatments for a large number of ED patients. There is a clear need for a PGE1 based product that is more acceptable to these patients in that it does not produce the penile pain experienced by such a large percentage of users. We look forward to finding a marketing partner to bring an improved PGE1 product to market.'

anal fissures

Cellergy has also said that the United Kingdom's Committee on Safety of Medicines (CSM) will recommend that marketing authorisation be granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) for Cellegesic (branded Rectogesic outside the United States) upon receipt of satisfactory responses to minor patient information and packaging specification issues. Formal approval is expected within the next several months.

Upon approval, Rectogesic (nitroglycerin ointment) will be indicated for the treatment of pain associated with chronic anal fissures. The MHRA has also agreed to act as a Reference Member State for regulatory filings of the product in other European Community Member States, a process that generally takes about six to nine months from the time formal approval is granted in the Reference Member State.

Cellegy's regulatory filing provided data demonstrating that Rectogesic produced a statistically significant reduction in pain versus placebo when given twice daily over an eight-week treatment period and was able to achieve its effect much more quickly than the placebo.

Forrest said: 'We are delighted to receive this first European regulatory determination from the CSM, which we also see as a validation of our clinical development program for Cellegesic/Rectogesic. This important product will soon be available to fissure sufferers in the UK, the first market in Europe in which Rectogesic will be approved, adding to availability in Australia, New Zealand and South Korea, where it was recently launched. In the United States, an NDA for Cellegesic has been submitted and is now being reviewed by the Food and Drug Administration.'

Anal fissures

It is estimated that there are over a million people in Europe who suffer from anal fissures, a painful condition for which there are no approved drug products and for which the only effective therapy is a surgical procedure that often leaves patients incontinent. Cellegy believes that the utility of nitroglycerin in treating anal fissures is well recognised and that the Company's product fills a large unmet medical need. Rectogesic, when available, will provide a uniform product manufactured under GMP conditions to MHRA approved specifications.