Industry News and Innovations

In ED, Physicians Say Opportunity Exists for More Effective Therapies
A report from Decision Resources (Waltham, MA), a leading research and advisory firm for pharmaceutical and health care issues, found that although surveyed primary care physicians (PCPs) are generally satisfied with the efficacy of available phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra, Pfizer), tadalafil (Cialis, Eli Lilly and Company), and verdenafil (Levitra, Bayer Healthcare/Schering-Plough/GlaxoSmithKline), they are less satisfied with the efficacy of this drug class in difficult-to-treat patient subpopulations. PCPs' satisfaction with available PDE5 inhibitors on key measures of clinical efficacy suggests that opportunity exists for improvement in the treatment of erectile dysfunction patients with comorbid conditions such as hypertension and diabetes, according to a news release from Decision Resources.

A report, "Erectile Dysfunction: Physicians Seek Improvements in Efficacy for Underserved Patients and Product Differentiation on Onset and Duration of Action," finds that a therapy that provides greater improvement in erectile function than verdenafil in patients with hypertension and that is priced at a 5% discount to verdenafil would earn a 50% patient share in the United States and a 40% patient share in Europe, according to surveyed US PCPs and European general practitioners.

Although there are several second-generation PDE5 inhibitors in clinical trials for the treatment of ED, interviewed experts do not expect these agents to provide efficacy superior to that of currently marketed drugs in this class. The report also finds that limited reimbursement for [ED] drugs and the availability of less-expensive generic versions of sildenafil beginning in 2012, will constrain the uptake of emerging PDE5 inhibitors.

"Most therapies for ED do not qualify for reimbursement by third-party payers," said Decision Resources Analyst Kathryn Benton. "As a result, many patients pay out-of-pocket for treatment—this will be among the factors that will cause premium-priced emerging therapies to struggle to capture market share."

Spray Helps Men With PE Last Longer After Penetration
PSD502, a new topical spray, is a safe and effective treatment for premature ejaculation (PE), according to a news release from the American Urological Association (AUA).

Researchers presented data on the spray's efficacy during a presentation of a randomized, phase 3, double-blind, placebo-controlled study at the 104th Annual Scientific Meeting of the AUA in Chicago. One current treatment for PE consists of topical creams with desensitizing agents which dull the penile skin and delay ejaculation. Although effective, these creams require use of a condom and/or washing the cream away before intercourse and they may reduce sexual pleasure, according to the AUA.

Researchers have shown that a new topical spray, consisting of an aerosol formulation of lidocaine and prilocaine, is effective and easy to use. It selectively desensitizes penile skin, affecting only the nonkeratinized skin (the inner lining of the foreskin and the surface of the glans), without adversely affecting the sensation of ejaculation. This new treatment can be applied 5 minutes prior to intercourse.

A total of 300 men with PE participated in this study. The participants were divided into two groups, one applied the PSD502 spray and the other applied a placebo spray 5 minutes prior to sexual intercourse. Both groups had an average baseline of 0.6 minutes latency time before ejaculation. After treatment, the PSD502 group improved to a latency time of four minutes; the placebo group only improved to 1 minute.

"PE is one of the most common sexual dysfunctions in men. It occurs in 20% to 30% of men of all ages and we need an effective, patient-friendly treatment for this distressing problem," said Ira D. Sharlip, MD, an AUA spokesman. "This [spray] has promise to become one of the most effective treatments for PE. It has a number of characteristics which will be attractive to patients with PE."

Apidra SoloSTAR Available in the United States
Sanofi-aventis US announced that Apidra SoloSTAR (insulin glulisine [rDNA origin] injection), a prefilled disposable pen containing the rapid-acting insulin analog Apidra, is now available in the United States. Apidra is indicated to improve glycemic control in adults and children (≥4 years) with type 1 diabetes or adults with type 2 diabetes, according to a company news release.

"Sanofi-aventis is committed to providing innovative tools to patients with diabetes that can help ease some of the challenges of blood sugar management," said Jerry Durso, Vice President, Specialized Therapeutics Business Unit, sanofi-aventis US. "Apidra SoloSTAR provides patients with a convenient option for administering their Apidra."

For more information, please visit www.apidra.com.