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One of the first companies
to seek approval for its antidepressant in a lifestyle indication
was Eli Lilly, with the blockbuster SSRI Prozac (fluoxetine).
In November 1999, an FDA committee recommended the approval
of Prozac for the treatment of premenstrual dysphoric disorder
(PMDD) - a severe form of PMT/PMS.
If approved, Prozac would become the first medication in the
US with a PMDD indication. The condition was said to affect
3-5% of women, and symptoms include lethargy and irritability.
Portugal and the UK have both granted Prozac full approval
in PMDD.
Lilly said it would be working with the FDA to obtain approval
- the company wishes to use a different brand name to avoid
the stigma associated with Prozac.
According to IMS HEALTH's Pharmacast
& Beyond, antidepressants are already prescribed much
more frequently to women then men - 68.75% versus 31.25%.
It states that Prozac will likely become available for PMDD
in a number of markets in 2000, growing the total number of
antidepressant prescriptions
(N6A) by an average of 1.6%.
Other possible lifestyle indications for antidepressants include:
- Bulimia
- Panic
- Post-traumatic stress disorder
- Sexual dysfunction
- Smoking cessation
- Social anxiety and shyness
- Weight loss
Glaxo Wellcome already markets a formulation of its antidepressant
Wellbutrin (amfebutamone or bupropion) as Zyban for smoking
cessation. Pfizer's Zoloft (sertraline) was the first drug
to win FDA approval for post-traumatic stress disorder, and
both drugs are being investigated in aiding weight loss -
while Prozac is also approved for bulimia.
The approval of SmithKline Beecham's Paxil/Seroxat (paroxetine)
for 'social anxiety disorder' (SAD, also known as social phobia)
was dismissed in some quarters as a cure for 'shyness', but
that has not stopped other companies running trials of their
antidepressants in SAD.
It is said to be the third most common psychiatric disorder
in the US, and involves fear of scrutiny by others, leading
to an avoidance of social situations, public speaking etc.
Gaining new indications is an ideal way for pharmaceutical
companies to extend the lifecycle of their antidepressants,
some of which are very lucrative products.
IMS HEALTH's Medical
Dynamics data reveals that prescriptions for Seroxat in
the UK for phobic anxiety disorder rose 249.6% in 1999 from
1998, to 9,300. Although this represented only 0.2% of Seroxat's
total prescriptions in the country, this figure is likely
to grow.
PMT accounted for 0.8% (69,200) of Prozac's total prescriptions
in the US in 1999, up from 0.5% in 1998. Medical Dynamics
will continue to track the trend for lifestyle prescribing
within the antidepressant class.
Available to buy and download now from IMS HEALTH:
Pharmaceutical Company
Profiles
Eli Lilly - Glaxo Wellcome - Pfizer - SmithKline Beecham
Sales Data - by therapy
area
Antidepressants (N6A)
Forecasts and Analysis
- by country
Antidepressant market (for UK, France, Canada, Japan, Spain,
Germany, Italy)
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