GSK, XenoPort file sNDA for Horizant
LONDON — Drug makers GlaxoSmithKline and XenoPort are seeking expanded approval for their restless legs syndrome treatment.
The drug makers this week announced the submission of a supplemental new drug application to the Food and Drug Administration, requesting approval for Horizant (gabapentin enacarbil) extended-release tablets as a treatment for postherpetic neuralgia, a nerve pain that commonly is seen in patients with shingles. GSK submitted the sNDA on behalf of the two companies.
Horizant initially received regulatory approval from the FDA in April as a treatment for moderate to severe primary RLS.
ShopRunner survey finds parents head to multiple places for BTS shopping
NEW YORK — A new survey conducted by online shopping service ShopRunner found that many parents will head to multiple stores to purchase back-to-school items for their kids.
Among the parents surveyed, nearly half (49%) said their biggest challenge is not finding everything their child needs at one store while back-to-school shopping. Because of this, more than two-thirds (61%) said they plan to visit three to four stores to fulfill their back-to-school shopping needs, while spending anywhere between five to 10 hours shopping (45%). When it comes to buying items for their kids online, however, nearly 75% of parents said they would prefer to do all of their shopping online but cited shipping costs as the No. 1 reason they forgo this option.
ShopRunner also noted that 48% of respondents said they will spend more money this year than in 2010, with 46% saying that they will spend $200 per child.
FDA approves single-pill HIV drug
FOSTER CITY, Calif. — The Food and Drug Administration has approved a new single-pill treatment for HIV made by Gilead Sciences and Johnson & Johnson, Gilead said.
Gilead announced the approval of Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate). The drug combines Gilead’s Truvada with J&J’s Edurant.
"In the 30 years since the first AIDS cases were reported, we’ve made incredible strides in the treatment of this disease," said Tony Mills, director of medical research at Anthony Mills MD Inc. and investigator in Complera studies. "The concept of a single-tablet regimen has become a goal in HIV drug development, and the standard of care in medical practice in the United States."