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FDA Approves Third Drug To Treat Erectile Dysfunction

Tags: ED, FDA approval

Treat Erectile Dysfunction

The Food and Drug Administration (FDA) today approved Cialis (tadalafil), an oral medication to treat erectile dysfunction (ED, or impotence) in men. This is the third oral product approved for this condition. This drug is different than currently approved products for ED in that it stays in the body longer.

Erectile dysfunction (ED) affects millions of men in the United States. Cialis acts by relaxing muscles in the penis and blood vessels, allowing increased blood flow into the penis, which produces an erection.

Canadian Cialis was evaluated in randomized, placebo-controlled trials involving more than 4,000 men with erectile dysfunction. In two of these trials, men had ED associated with diabetes mellitus or following radical prostatectomy for prostate cancer.

The drug’s effectiveness was assessed using a sexual function questionnaire. In addition, patients were asked to report if they were able to achieve an erection adequate for intercourse and whether that erection was maintained to allow completion of intercourse. In all of these trials, Cialis pills improved patients’ ability to achieve and maintain a penile erection. In other studies, sexual activity was improved in some patients at 30 minutes after taking a dose; additional studies demonstrated improvements for up to 36 hours after taking Cialis when compared to placebo.

The recommended starting dose for most patients is 10 mg taken prior to anticipated sexual activity. A higher dose of 20mg is available for patients whose response to the 10mg dose is not adequate. A lower dose (5 mg) is also available and may be necessary for patients taking other medicines or having medical conditions that may decrease the body’s ability to metabolize tadalafil. Cialis tablets should not be used more than once per day.

Cialis should not be used with nitrates (such as nitroglycerin tablets or patches) or with an alpha blocker other than FLOMAX 0.4 mg daily (alpha blockers are medicines used to treat benign prostatic hyperplasia and high blood pressure) because the combination may significantly lower blood pressure and lead to fainting or even death in some men.

Because some drugs affect the metabolism of Cialis, patients should inform their doctors that they are taking Cialis. For example, patients taking ketoconazole or ritonoavir should not take more than a 10mg dose of Cialis once every 72 hours.

Also, in patients with moderately or severely decreased kidney function, the starting dose is 5mg taken once daily. In this group, the dose may be increased to 10mg taken once every 48 hours. In patients with mild or moderate liver impairment, the maximum dose of Cialis is 10mg.

In most patients, after taking a single dose of generic Cialis, some of the drug will remain in the body for more than 2 days. In those with decreased kidney function, impairment of the liver, or those taking certain medications (e.g. ketoconazole or ritonavir) tadalafil can remain in the body longer.

Cheap Cialis should not be taken by men in whom sexual activity is inadvisable because of their underlying cardiovascular status (heart condition). Patients should inform their doctor about any heart problems that they have experienced before taking Cialis.

Generic Cialis is not recommended in patients who have suffered a heart attack or stroke within the last six months, or patients who have significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe liver impairment, or retinitis pigmentosa (an eye disorder).

The most common side effects reported in clinical trials included headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. Patients who get back pain and muscle aches usually get it 12 to 24 hours after taking generic Cialis and these usually go away by themselves within 48 hours. A small number of patients taking Cialis also reported abnormal vision.

Before taking Cialis drugs, patients are advised to undergo a thorough medical history and physical examination to attempt to diagnose the underlying cause of the erectile dysfunction and to identify appropriate treatment.

Source: FDA Talk Paper #T03-79, November 21, 2003

USA approval for once daily Cialis pill

Published in News

USA approval

Eli Lilly’s once-a-day version of its erectile dysfunction (ED) treatment Cialis (tadalafil) has finally got the go ahead from US regulators, six months after approval in the EU.

The approval means the new formulation is now available to men on the other side of the Atlantic, allowing sufferers of ED to attempt sexual activity at any time between doses, rather than during the narrow time frame dictated by the ‘on demand’ version.

According to Lilly, the once daily Cialis formulation is intended for men who anticipate more frequent sexual activity (i.e. twice weekly), and contains a lower dose than the previously approved version that is taken as needed.

The newly approved formulation, aside from offering perhaps a more convenient and attractive option to men, will also be no more taxing on their wallets. According to Lilly, the wholesale pricing for the once-daily Cialis will be comparable to the as-needed formulation, so that patients who currently use two or more pills of the as-needed version should not have higher treatment costs through using the once-daily product.

Gaining EU approval in June last year, the once-a-day product is currently available only in parts of Europe, but introduction to further countries is expected throughout 2008.