FDA approves Wyeth antidepressant Pristiq
WASHINGTON The Food and Drug Administration recently approved the antidepressant drug Pristiq, manufactured by Wyeth.
The approval sparked a bit of controversy, however, as Pristiq bears a striking resemblance to Wyeth’s former best-selling antidepressant Effexor XR, for which Wyeth recently lost its patent protection, according to the New York Times. Effexor sells for $120 for a 30-day supply while the generic version is sold for less than half that price.
Wyeth applied for FDA approval in 2005, just received its approval on Friday. Even though there are similarities between the two drugs, the Times reported, one difference is patients can start taking Pristiq at 50 milligrams, as opposed to other antidepressants which have to be started at a very low dose until the patients and their doctors figure out their correct dose. Another difference is that it does not need to be broken down by the liver and therefore does not interact with other medications that are metabolized by the liver.
The president of Wyeth, Geno Germano, has insisted that Pristiq is another great addition, because physicians and patients need a variety of choices to find the right antidepressant medication, but many analysts are still skeptical, saying that there are not many major advantages to using this new drug.
“Is there a compelling public health reason for Wyeth to be releasing another antidepressant into the market, with no clear advantages over others?” said Daniel Carlat, a psychiatrist in Massachusetts who publishes the Carlat Psychiatry Report. “Not that I can see.”
Even though there are mixed reviews of the potential success of this new drug, shares for Wyeth increased 2.5 percent, closing at $43.62 upon FDA approval.
Combo vaccine for kids linked to fever and seizures
ATLANTA A study by the Centers for Disease Control and Prevention has shown that children suffered higher rates of fever-related convulsions when they got a Merck combination vaccine instead of two separate shots, according to published reports.
Prior to the findings, the CDC’s Advisory Committee on Immunization Practices had stated a distinct preference for the ProQuad vaccine, which protects against measles, mumps and rubella as well as chickenpox. The committee’s argument was that it would be better to give children the fewest injections possible.
Now, however, the committee has withdrawn its preference for ProQuad, choosing not to exhibit any preference at all. “Safety, shortages, delivery issues—lots of reasons not to state such a strong preference,” said a committee member. ProQuad costs $124 per dose, about the same as the two other shots combined.
In the study of children ages 12 months through 23 months, the rate of seizures was twice as high in toddlers who got ProQuad, compared with those who got one shot for chickenpox and one for the three other diseases. Neither the convulsions, nor the fevers that engendered them resulted in any child deaths. Merck has conducted its own study with similar results: 1 occurrence in approximately 2,000 children.
Procter & Gamble wins patent suit for Actonel
CINCINNATI The United States District Court of Delaware today ruled in favor of the Procter & Gamble Company in the patent infringement lawsuit filed by P&G against Teva Pharmaceuticals. The positive ruling protects P&G’s rights in the U.S. to exclusively market the osteoporosis therapy Actonel (risedronate sodium tablets).
P&G filed a patent infringement lawsuit in August against Teva to enforce P&G’s U.S. composition of matter patent for risedronate, the active ingredient in Actonel. Teva was seeking to market a generic version of Actonel in the United States under the assertion that the Actonel patent was not valid due to obviousness of the invention.
The court ruled today in favor of the patent. “We are pleased that the Court recognized and acknowledged the uniqueness of the risedronate molecule,” said Tom Finn, P&G president of global health care. “We are very proud of the extensive R&D efforts which brought Actonel to market, providing patients help that they need to manage their osteoporosis and prevent fractures.”