Labopharm Inc. says an additional Phase 3 clinical trial may be needed to satisfy U.S. Food and Drug Administration in an approval application for its once-daily painkiller tramadol.

The company said a recent meeting with the agency "was productive" and the statistical analysis needed for approval "has been clearly delineated."

Ortho-McNeil, Inc. has announced that it settled its patent litigation against Par Pharmaceutical Companies, Inc. and its subsidiaries, Par Pharmaceutical, Inc., and Kali Laboratories, Inc., generic drug manufacturers, regarding their infringement of the Ortho-McNeil patent for Tramadol.

A doctor gave Tramadol during the party

Dr Graeme Wilson, of Chorlton, Manchester, was giving Tramadol to guests at a party at his home.
The General Medical Council (GMC) heard how he told one woman they would make her "mellow". Another guest became ill and was taken to hospital.
The doctor was found guilty of impairment by reason of misconduct at a hearing in Manchester. Dr Wilson asked a woman at the dinner party if she "did drugs".
A judgment read by the panel chairman said: "You told her that you were a doctor and you then took a foil strip from what appeared to be your doctor's bag.
"She reported feeling very floaty but tired and lost track of time.
"She also stated that her balance was so bad that she had to crawl up the stairs to the toilet.
"This case involves one isolated event in which the Panel found that you recklessly persuaded your two dinner guests to take Tramadol.
"The Panel found that, in doing so, you abused the position of trust which is placed in you as a doctor and breached fundamental principles of Good Medical Practice.
"Your misconduct has, therefore, damaged public confidence in the medical profession."