Posted by MOB on November 15, 2001 at 11:43:10:
This is all I could find for now - will have a better look later. No one who I have spoken to has heard anything about it ?
FDA approves Elan's migraine drug Frova™ (frovatriptan succinate)
DUBLIN, IRELAND, November 9, 2001 -- Elan Corporation, plc
NYSE: ELN) ('Elan')announced today that the U.S. Food and
Drug Administration approved Frova™ (frovatriptan
succinate) 2.5 mg tablets, for the acute treatment of
migraine attacks with or without aura in adults.
Donal J. Geaney, chairman and chief executive officer of
Elan commented, 'The FDA's approval of Frova is a key
milestone in advancing our pipeline of important products
for patients with neurological disorders. We are excited to
bring to patients who suffer from migraine headaches,
Frova, a new medicine for migraine. We are in discussions
with potential co-promotion partners and expect to conclude
our launch plan this quarter.'
Approximately 10% of the U.S. population suffer from
migraine attacks. Of these 27 million sufferers, over 50%
remain under-diagnosed or under-treated. The U.S. market
in 2001 for migraine therapy is expected to be
approximately $1.4 billion for the overall triptan class
with the oral triptans representing $1.2 billion.
The efficacy and tolerability of Frova was demonstrated in
five randomized, double blind, placebo-controlled trials.
According to Arthur Elkind, MD, Director of the Elkind
Headache Center, Mt. Vernon, New York, 'My experience with
frovatriptan in a long-term, open label trial indicates it
is an effective treatment and provides a high degree of
In a market in which only 29% of patients report they are
very satisfied with their migraine therapy, the benefits of
Frova make it an important alternative therapy in the
treatment of migraine for many patients. Migraine attacks
typically last four to seventy-two hours. Frova 2.5 mg
tablets have a 26-hour half-life. Frova may represent an
important advancement in the treatment of migraine headache
as no other currently marketed triptan has a half-life of
more than six hours. Stephen Silberstein, MD, Director,
Jefferson Headache Center, Philadelphia, PA said, 'The
addition of frovatriptan, with its long half-life, gives
physicians another alternative to managing patients.'
Frova is a 5-HT receptor agonist that binds with a high
affinity for the 5HT1B and 5HT1D receptors and is believed
to act on extracerebral, intracranial arteries and to
inhibit excessive dilation of these vessels in migraine.
Frova was well-tolerated in clinical trials. The side
effects that occurred most frequently following
administration of Frova 2.5 mg tablets (in at least 2% of
patients, and at an incidence of >1% compared to
were dizziness, paresthesia, headache, dry mouth, fatigue,
flushing, hot or cold sensation and chest pain.
Post a Followup