Following FDA approval in May, Carmel Valley-based Novalar Pharmaceu & #173;ti & #173;cals launched its first product Feb. 27 at a national dental convention in Chicago.
OraVerse, an injection made with an anti-hypertensive drug, works to reverse the numbing effects of dental anesthesia in half the time.
In clinical studies, the majority of patients receiving the drug returned to normal sensation within 15 minutes to an hour. OraVerse is approved for children as young as 6 years old.
“It’s really an exciting day,” said Novalar CEO Donna Janson in a telephone interview following its official public debut. “It’s amazing, you spend four and a half years and the day is finally here. It’s just really surreal.”
A 24-person sales team will begin introducing the product to dentists in California, Florida, Illinois, New York, Texas and the Washington, D.C., area. It will charge dentists between $12 and $18 a cartridge, depending on volume, Janson says.
Novalar says it aims to capture 20 percent of the market for the 275 million cartridges of local dental anesthetic sold each year in the U.S., and says the market could be as large as $600 million.
“We think the (dentists) more interested in new technologies and the ones that are doing aesthetic dentistry will be a good target for us to start with,” Janson said.
Novalar doesn’t expect the recession to negatively affect OraVerse sales because, Janson says, people will not put off routine dental care such as cavity fillings and deep cleanings.
“I do think we have some advantage in that our product is used for very, very routine procedures,” she said.
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No On Drug Approval:
The FDA issued a complete response letter to San Diego-based Somaxon Pharmaceuticals on Feb. 27, saying it could not approve its insomnia drug Silenor without further proof that the drug does not prolong cardiac QT intervals.
Prolonged QT intervals can cause the heart’s electrical system to go haywire, leading to abnormal heart rhythm.
The news dealt a major blow to the company, which saw its shares fall to a
52-week low following the announcement.
Somaxon stock, traded under the symbol SOMX on Nasdaq, fell 80 percent Feb. 27 to close at 44 cents.
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