Archive for the ‘Articles’ Category

FDA Wants Men on ED Drugs to Listen Up

Wednesday, November 7th, 2007

The Food and Drug Administration has asked makers of the drugs to put a warning to that effect on product labels. The alert comes two years after the drugs were linked to rare cases of vision loss, caused by a disruption in blood supply to the optic nerve.

The latest alert was prompted by a case report in the Journal of Laryngology & Otology of sudden hearing loss in a man taking Viagra. A search of FDA records found 29 similar reports involving ED drug users and a few people who took the drugs during clinical trials.

Although hearing loss is common in men in their 50s — the age group most likely to take ED drugs — age-related loss tends to be gradual, unlike the kind tied to the warning. The FDA has also issued a hearing-loss warning on Revatio, a blood pressure drug in the same class. Revatio users who experience hearing problems should stay on the drug until they have checked with their doctor.

ED drugs, on the market for more than a decade, generally have an excellent safety record. More-common problems include flushing and muscle soreness.

Francesca Lunzer Kritz

Viagra ‘works for women’

Wednesday, November 7th, 2007

Women may be able to benefit from the anti-impotence drug Viagra, Italian researchers suggest.

The results of their study conflict with earlier research projects which found little significant improvement among women who took the drug.

Viagra was initially designed as a drug to treat sexual problems in men, improving blood flow to the penis.

However, it has long been suspected that its effect might help many of the women who suffer the equivalent form of sexual dysfunction - an inability to either attain enough sexual arousal or to maintain it.

Sexual dysfunction in women is reportedly more common in women than impotence is in men.

The research concentrated on 53 women in their 20s - all affected by disorders restricting their ability to get sexually aroused.

Over four weeks, they were given either a placebo, or Viagra, then questioned about any changes.

The results suggested that both arousal and the ability to achieve orgasm both improved when Viagra was being taken.

‘More satisfied’

The authors of the study, from the Centre for Sexological Research in the University of Catania, found women taking the drug said they were more satisfied by sex than those taking the placebo.

Viagra has been a multi-million dollar moneyspinner for Pfizer, the drug company which developed it, although other anti-impotence drugs are starting to approach the marketplace.

In the UK, the NHS is prepared to pay for a rationed quantity of tablets for men whose impotence is found to have a definable physical cause, or for whom it is causing significant psychological distress.

However, the NHS is not currently prepared to provide Viagra for women.

However, even Pfizer is somewhat sceptical about the latest research.

A spokesman for the company said: “To date, Pfizer’s female sexual dysfunction (FSD) studies demonstrate that while Viagra has been well-tolerated, it has not shown a significant increase in reported sexual arousal.

“Salvadore Caruso’s research is an interesting study that we will review as part of our ongoing research.

“Other Pfizer studies in FSD are ongoing including a phase II programme which is part of new research providing insight into various aspects of the condition.

“Results of this should be completed within the next year.”

The research was published in the British Journal of Obstetrics and Gynaecology.

Pfizer Emerges Victorious in China Viagra Patent Battle

Wednesday, November 7th, 2007

Following a six year legal battle, Pfizer Inc. (NYSE: PFE) has successfully defended its Chinese patent on the erectile dysfunction drug Viagra. As reported in Chinese in the 21st Century Economic Report on Nov. 1, the Beijing High People’s Court has issued a final judgment on the patent dispute. Rejecting a patent challenge from 12 domestic drug manufacturers, the high court’s final judgment grants Pfizer patent protection on Viagra until 2014.

Pfizer initially filed a Chinese patent application in May 1994 for the use of Sildenafil (Viagra) in the treatment of erectile dysfunction treatment.

After seven years of investigation, the China State Intellectual Property Office [SIPO] granted the patent in 2001. The patent was challenged by 12 domestic Chinese drug companies that claimed to have invested over US$12 million to produce generic versions of the drug.In July of 2004, SIPO’s Patent Review Bureau invalidated Pfizer’s patent. The rejection was based on a claimed lack of data in the application to support Viagra’s specific therapeutic effect. The ruling sparked international attention and became a high profile test case for China’s commitment to the protection of intellectual property rights.

Pfizer immediately challenged the decision, and in June 2006 the Beijing Intermediate People’s Court ruled in favor of Pfizer after one and half years of review. This ruling was appealed by the domestic drug manufacturers to the Beijing High People’s Court. The High Court on Thursday rejected the appeal and instructed SIPO to withdraw its opposition to the drug.

The decision should reaffirm Viagra’s position in the Chinese market for erectile dysfunction drugs. It is estimated that the combined legitimate and underground markets for ED drugs in China is CNY 20 billion (US$2.7 billion). Pfizer still faces some challenges however. Earlier this year the company lost a trademark infringement case with a domestic maker of sildenafil over the usage of the brand “Wei Ge” or “Mighty Brother”. “Wei Ge” is the trade name used by Pfizer to market the drug in China. Pfizer has filed an appeal.

Disclosure: Author has a long position in Pharmaceutical HOLDRs (PPH)