• Home

Ministry approves new drug

Cialis (Tadalafil), a new highly selective oral PDE-5 inhibitor, which is available in pharmacies in Europe, Australia and New Zealand, has been approved by the ministry and will be registered within two months, said Dr Issa bin Jakka Al Mansouri, Director of the Department.

Currently, Viagra is the only FDA-approved oral drug for the treatment of ED. However, Cialis was approved for the treatment of mild to severe ED in both 10mg and 20mg doses.

Stimulation is needed for Cialis to work effectively. According to the European label, the efficacy of Cialis may persist up to 24 hours after the pill is taken. In Australia, the label indicates efficacy up to 36 hours after each dose.

More than 4,000 men have taken part in over 60 studies that characterised the safety and efficacy profile of Cialis. In primary efficacy studies involving 1,112 men (804 Cialis, 308 placebo) with mild to severe ED, up to 81 per cent of those treated with Cialis showed improvement compared with 35 per cent of those taking placebo.

The most commonly reported adverse effects were headache, upset stomach, nasal congestion, backache, muscle ache, dizziness and flushing. The adverse effects reported with Cialis were transient and generally mild or moderate. As with other PDE-5 inhibitors, the use of Cialis is contraindicated in patients who are taking nitrates. It should not be taken by patients with certain heart diseases.

ED affects an estimated 152 million men worldwide. Up to 80 per cent of ED cases are caused by physiological conditions, including cardiovascular disease and diabetes, with psychological factors accounting for the remaining 20 per cent.

• UAE