UK and Europe

World Wide

Avodart | Avodart V's Propecia | Clinical Trial

On October 10 2002 the FDA approved Avodart, ( Dutasteride )  the first dual-acting 5 alpha-reductase inhibitor for benign prostatic hyperplasia (BPH)

Dutasteride was approved by the Swedish regulatory authority (MPA) on July 24th 2002. It will be marketed in Sweden by the trade name AvolveÒ.

The MPA agreed to act as the Reference Member State for the Mutual Recognition procedure within Europe and GSK plan to market the drug in all major European markets once approvals are finalised during 2003.

The European trade name (Avolve) is to be confirmed.

Avodart ( Dutasteride ) is being released for the treatment of the prostate.

It is not clear at the moment when Glaxo will proceed with hair loss trials.

Side Effects

• Dutasteride should not be used in women and children. Women who are pregnant or may become pregnant should not handle dutasteride because of possibility of absorption of dutasteride and subsequent potential risk to a male foetus.
  
  
• Men treated with dutasteride should not donate blood until at least six months after their final dose to prevent giving dutasteride to a pregnant woman through a blood transfusion.
  
  Men with an allergic reaction to dutasteride or its ingredients should not take it. Men with liver disease should talk to their doctor before taking dutasteride.
  
  
• Clinical trials of dutasteride showed that it was generally well tolerated. Most side effects were mild or moderate and generally went away while on treatment in both the dutasteride and placebo groups.
  
  
• Drug-related side effects during the first six months were as follows: impotence (4.7 percent vs. 1.7 percent for placebo), decreased libido (3 percent vs. 1.4 percent), breast tenderness and breast enlargement (gynecomastia; 0.5 percent vs. 0.2 percent) and ejaculation disorders (1.4 percent vs. 0.5 percent).
  
  
• The incidence of most drug-related sexual adverse events decreased with duration of treatment.
  
  The incidence of drug-related breast tenderness and breast enlargement remained constant over the treatment period.
  
  Ejaculate volume may be decreased in some patients with continued treatment. This decrease did not appear to interfere with normal sexual function.

Dutasteride is the first 5-alpha reductase enzyme inhibitor (5ARI) that inhibits both types 1 and 2 isoenzymes. These enzymes are responsible for converting testosterone to dihydrotestosterone (DHT) in the prostate, which are proven to play a key role in the development and progression of BPH and hair loss.

The good news is that Phase III trials have already been completed for Benign Prostatic Hyperplasia and the drug has been given preliminary approval by the FDA.

It is thought that dutasteride will be sold and marketed sometime next year. Finasteride followed a similar course and was first approved for BPH and then later for hair loss.

Very little Dutasteride is required to inhibit type 1 5-alpha-reductase but very large quantities of Propecia are required to do so. For type 2 5-alpha reductase (the one Propecia blocks), even less

Dutasteride is required to block it than Propecia. So small doses of Dutasteride provide very good inhibition of both types of the 5-alpha reductase enzyme.

UK and Europe

World Wide

Avodart | Avodart V's Propecia | Clinical Trial