Pharmaceutical International News - April 2012
Vivus Erectile Dysfunction Drug Stendra FDA-Approved
Posted by Paul Fiddian - Pharmaceutical International's Lead Reporter on 30/04/2012 - 15:40:00
Erectile dysfunction treatment Viagra now has a potential US market rival in the form of Vivus Inc's Stendra (avanafil).
Approved by the US Food and Drug Administration at the end of April 2012, Stendra is quicker to work than its older counterpart and it's the first drug of its kind to be launched in 10 years. It's therefore likely to be a commercial success and, once on the US market, will join GlaxoSmithKline and Bayer's Levitra, as well as Viagra.
"This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs", FDA Office of Drug Evaluation deputy director, Victoria Kusiak, explained in a statement.
Stendra Erectile Dysfunction Drug
Like Viagra and Levitra, Stendra is a PDE5 inhibitor class-drug and it stimulates the flow of blood into the penis but, unlike the others, it's been shown to be selective: a factor that could limit its side-effects.
According to Vivus, up to 30 million US residents suffer from erectile dysfunction and, while it's now cleared for this demographic, erectile dysfunction patients in the EU will have to wait a little longer before regulators there approve it in a similar way.
Patients who take Stendra are advised to expect give the drug a 30 minute window before it starts to have a physical effect. However, under clinical trial conditions, it's produced the same effect within 15 minutes - a four times-speedier response that Viagra can manage, on average.
FDA Vivus Stendra Approval
The FDA Vivus Stendra approval covers the drug in three strengths: 50mg, 100mg and 200mg. When it comes to which strength to prescribe, doctors are advised to prescribe on a patient-by-patient basis.
"Patients and treating physicians continue to report significant dissatisfaction with current treatments of ED", Vivus' president, Peter Tam, stated in a company press release. "We believe that the PDE5 selectivity and absorption profile of Stendra make it an important new treatment option for many men with erectile dysfunction."
Image used solely for representational purposes
Recently Added News
Financial analysts have tipped the newly-emerging immunotherapeutic class of cancer drugs for success, forecasting $35bn in annual sales for them
According to a new study, one in ten US sophomore students are using prescription drugs to aid studying without their parents knowing.
Newly-developed prescription algorithm gives doctors the tools to weigh up the risks and benefits of prescribing aspirin to particular patients
According to a new study, up to three quarters of pharmacies give poor medical advice, including giving dangerous drug combinations.