More Studies Needed For P&U's Halcion

11 December 1997

The US Food and Drug Administration's psychopharmacological panel hasrecommended that more studies be conducted on Pharmacia & Upjohn's sleeping pill Halcion (triazolam), but supported an Institute of Medicine report which found the drug to be safe and effective at the recommended dose.

After reports several years ago that the drug caused severe mood swings (Marketletters passim), the FDA said that Halcion was safe and effective when used as directed, stressing that it should be used for short-term therapy only. A maximum of 10 tablets of Halcion are supposed to be dispensed at a time.

The committee said that the drug was clearly being used for longer than the recommended period and that studies were needed to determine long-term effects. Members also voted in favor of studies of lower doses, noting that many questions about Halcion applied to other sedatives as well as antipsychotic drugs.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight