FDA approves Novartis’ Focalin for treatment of ADHD
EAST HANOVER, N.J. The Food and Drug Administration has approved a 30-minute onset of action for Novartis’ Focalin XR extended-release capsules for treating attention deficit hyperactivity disorder.
Novartis said the approval would bring potential benefits for young patients and their families during the morning period when they are preparing for school.
“The morning is a critical time for families,” Baylor College of Medicine associate professor of psychiatry Alice Mao said in a statement. “The early onset of Focalin XR provides symptom control which may help families and children living with ADHD get through their morning routine.”
Clinical studies, including a recent one, have shown that the drug, known generically as dexmethylphenidate hydrochloride, provided significant improvements at 30 minutes post-dose compared to placebo in measures of attention, deportment and academic productivity.
FDA raises questions about efficacy of pain medication tamper-proofing
NEW YORK Questions have arisen as to whether a pill by Pain Therapeutics and King Pharmaceuticals is resistant to tampering.
A memo by the Food and Drug Administration Monday concerns the drug Remoxy, a formulation of oxycodone that uses liquid capsule drug-delivery technology designed to prevent misuse of the drug. Some people have abused oxycodone tablets by crushing them, dissolving it in water and then injecting it for its opiate-like effects.
The FDA’s memo said that Pain Therapeutics did not sufficiently conduct long-term tests of Remoxy to determine whether the oxycodone could be extracted and diverted, though Pain Therapeutics disputes that claim.
Titan releases earnings report for Q3 2008
SOUTH SAN FRANCISCO, Calif. Titan Pharmaceuticals has released financial results for third quarter 2008.
Total operating costs for the quarter, which ended Sept. 30, were $6 million, compared with $4.6 million for third quarter 2007, the company said. Net loss for the quarter was $5.9 million, compared to $4.3 million last year; losses in both cases totaled 10 cents a share. The increase in operating costs resulted mostly from an increase in research and development funding related to development of the opiate addiction treatment Probuphine (buprenorphine) and a slight increase in general and administrative costs.
“We have continued to streamline our expenses and focus our resources on the phase 3 clinical development of Probuphine,” Titan president and chief executive Marc Rubin said. “During the third quarter, we have engaged in discussions with several potential partners both in the U.S. and Europe, and we are continuing these efforts as we evaluate strategic alternatives for the company.”