Could someone comment on what the problem might be if, as stated, it is not safety? Is it more difficult to move from oral to injectable or vice versa? Or does this not matter? Sure, that probably is a dumb question but in other cases posters appear to assume it will be a slam dunk to produce an oral version of an I.V. or I.M. drug.
Monday July 1, 8:53 am Eastern Time
Reuters Company News
FDA rejects J&J's injectable Risperdal
(adds stock price, details in paragraphs 2, 7)
NEW YORK, July 1 (Reuters) - The U.S. Food and Drug Administration has rejected a bid by health-care products
maker Johnson & Johnson (NYSE:JNJ - News) and partner Alkermes Inc. to market a long-acting, injectable version of
the lucrative schizophrenia treatment Risperdal, the companies said on Monday.
Shares of Cambridge, Massachusetts-based Alkermes (NasdaqNM:ALKS - News), a
small firm focused on drug-delivery technologies, plunged in premarket trading,
falling more than 50 percent to $7.95 from a Friday close at $16.01 on Nasdaq.
J&J, of New Brunswick, New Jersey, said the FDA had questions about preclinical
data relating to the new version of the drug, called Risperdal Consta. Preclinical data
usually stems from the testing of a drug in animals.
"We believe we will be able to satisfactorily resolve the FDA's questions about the
preclinical data," said Dr. Harlan Weisman, executive vice president of research and
development at J&J's pharmaceutical research and development operations.
Risperdal, often administered to elderly patients in nursing homes, had first-quarter
sales of $547 million, up 21 percent. The drug is currently administered as a pill or an
oral liquid solution.
A spokeswoman for J&J said additional discussions with the FDA were needed
before the companies could decide whether additional clinical trials would be
necessary.
She said the safety of Risperdal was not in question. |
