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FDA Approval = Huge Rise in …

viagra

March 27, 1998: FDA Approves Viagra

On this day in 1998, the Food and Drug Administration (FDA) approves use of the drug Viagra, an oral medication that treats impotence.

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Sildenafil, the chemical name for Viagra, is an artificial compound that was originally synthesized and studied to treat hypertension (high blood pressure) and angina pectoris (a form of cardiovascular disease). Chemists at the Pfizer pharmaceutical company found, however, that while the drug had little effect on angina, it could induce penile erections, typically within 30 to 60 minutes.

Viagra_in_PackSeeing the economic opportunity in such a biochemical effect, Pfizer decided to market the drug for impotence. Sildenafil was patented in 1996, and a mere two years later–a stunningly short time compared to other drugs–it was approved by the FDA for use in treating “erectile dysfunction,” the new clinical name for impotence. Though unconfirmed, it is believed the drug was invented by Peter Dunn and Albert Wood.

Dunn and Wood worked on the crucial nine-step process to synthesize a Sildenafil compound into a pill.

Steps In Making Viagra

  1. Methylation of 3-propylpyrazole-5-carboxylic acid ethyl ester with hot dimethyl sulfate
  2. Hydrolysis with aqueous NaOH to free acid
  3. Nitration with oleum/fuming nitric acid
  4. Carboxamide formation with refluxing thionyl chloride/NH4OH
  5. Reduction of nitro group to amino
  6. Acylation with 2-ethoxybenzoyl chloride
  7. Cyclization
  8. Sulfonation to the chlorosulfonyl derivative
  9. Condensation with 1-methylpiperazineviagra

Viagra’s massive success was practically instantaneous. In the first year alone, the $8-$10 pills yielded about a billion dollars in sales.

Viagra’s impact on the pharmaceutical and medical industries, as well as on the public consciousness, was also enormous. Though available by prescription only, Viagra was marketed on television, famously touted by ex-presidential candidate 102233Bob Dole, then in his mid-70s. Such direct-to-consumer marketing was practically unprecedented for prescription drugs (now, sales and marketing account for approximately 30 percent of the pharmaceutical industry’s costs, in some cases more than research and development). The drug was also offered over the internet–customers needed only to fill out an “online consultation” to receive samples.

Israeli and Australian researchers discovered that 1 mg of the drug dissolved in a vase of water can extend the shelf life of cut flowers, making them stand up straight for up to a week beyond their natural life span. Go figure.

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2-2001-09-30

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