Bupivacaine granted FDA’s orphan drug status
CUPERTINO, Calif. The Food and Drug Administration has granted orphan drug designation for bupivacaine, the active ingredient of Durect’s transdermal patch Eladur, Durect announced Monday.
Unlike other anesthetic patches, which last for up to 12 hours, Eladur will last for three days. The drug is designed to relieve pain associated with post-herpetic neuraligia and herpes zoster infection.
Durect will have exclusive marketing rights for Eladur for seven years if it is the first bupivacaine product the FDA approves for post-herpetic neuraligia.
AstraZeneca markets bupivacaine products under the names Marcaine and Sensorcaine. Sales figures for bupivacaine products were not available from AstraZeneca.
InstaClinic temporarily shuts down; in talks with potential partners
ST. LOUIS Less than two years after opening, all four InstaClinic locations have closed, according to the St. Louis Post-Dispatch.
Still, Schnuck Markets, which housed the clinics in its stores, and Patti Sohn, the nurse practitioner who launched them, say they might return.
Sohn described InstaClinic as “in transition” and “restructuring.” She said how many clinics open and their locations will “hinge on continued discussions with Schnucks and our other potential partners.” Sohn said, “Much depends on community need and the physical space available within the various Schnuck markets.”
Michael Juergensmeyer, Schnucks’ vice president of pharmacy, said Sohn, the chain and potential partners are in discussions. He said they’ve spoken with a potential partner interested in opening several clinics in Missouri and another with interest in opening clinics in Illinois.
Merck, Schering-Plough end Claritin-Singulair combo partnership
KENILWORTH and WHITEHOUSE STATION, N.J. Merck and Schering-Plough have withdrawn their application for a combined respiratory drug featuring Schering-Plough’s Claritin and Merck’s Singulair, according to Reuters. This ends an eight-year partnership between the two companies over the proposed drug.
In April, the Food and Drug Administration rejected the combination pill. Both drugs are allergy medications and the companies were hoping that the new combination pill would extend the lucrative franchises.
Claritin is now sold as an over-the-counter allergy treatment and generic versions are available, while asthma-and-allergy drug Singulair was Merck’s biggest-selling product last year with $4.3 billion in sales.
As a result of terminating the respiratory joint venture, Schering expects to receive $105 million from Merck, which Schering will recognize over the remaining three quarters of 2008.