FDA Watch: Painkillers on the Fall/Winter Agenda

The accompanying table (click on image to enlarge) presents an updated calendar of expected FDA decision dates.

Surprisingly, the FDA issued a complete response letter to Abbott Labs (ABT) for Vicodin CR, an extended-release version of the widely used painkiller that the company expected to be approved this quarter. Three more companies face key FDA decision in the month of December for abuse-resistant forms of opiate pain drug candidates.

King Pharma (KG) and Pain Therapeutics (PTIE) await a decision on Remoxy while Alpharma (ALO) has applied for approval of Embeda. Also, Alpharma has rejected an unsolicited $1.6B bid by King Pharma, which extended the date of the tender offer until 21-November.

Comments

[Tom W.:]

When doctors are able to diagnose pain, and the true effects it has on people, will the abuse reduce. As it sets now, many are given these of class drugs that are abused, which creates the same condition that actually needy are rejected for. When somebody is suffering and cannot get relief, which is truly has many more secondary conditions, can only be considered "hell on earth".
The new approved medications that are coming out really should be still considered in clinical stage as many complications happen and without targeted effectiveness for pain. And at some cost that many are not capable of paying, as these patients are most likely unable to work, poor, or retired.

2008 Oct 23 07:14 AM

[nybangali:]

Abbot has been showing up on my fundamentals screen for a while now. I post them for free on my website

2008 Oct 23 07:13 PM