A health ministry expert panel on Thursday approved over-the-counter sales of a drug to treat erectile dysfunction.
Tokyo-based drugmaker SSP sought the ministry's OTC sales permission for the drug called Cialis.
Cialis will become the first erectile dysfunction treatment that can be purchased at drugstores in Japan once the health minister gives endorsement after public comments are gathered. Guidance from pharmacists will be required for purchases at drugstores.
SSP expects that the start of OTC sales of the drug will help spread opportunities for erectile dysfunction treatment as male sexual dysfunction has major impacts on society, such as being a factor in declining birthrates.
Currently, diagnoses and prescriptions by doctors are needed to obtain erectile dysfunction drugs. SSP acquired a license for Cialis from Nippon Shinyaku, a drugmaker based in the city of Kyoto, which makes the drug, and filed for the ministry's approval for its OTC sales.
The ministry panel decided to limit Cialis purchases to men age 18 and older. At drugstores, patients will be able to buy Cialis after receiving guidance in person from trained pharmacists.
In and after May 2026, when the revised pharmaceutical and medical device law is expected to take effect, online purchases of Cialis will become possible on the condition that an explanation is given by pharmacists.
Cialis, an oral drug, can improve symptoms of erectile dysfunction for up to about 36 hours after it is taken before sexual intercourse.
People who have developed serious liver disorders or experienced myocardial infarction within the previous three months cannot use Cialis. The drug may cause side effects such as rash and hives.
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