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    Drug to Reverse Effects of Dental Anesthesia Gets FDA Approval

    By Jennifer Huddleston, staff writer       

    A new drug that reverses the numbing effects of local anesthesia used by dentists has been approved by the Food and Drug Administration (FDA) and will be available later this year. [1] Clinical trials of the drug showed that it reduced the median time for full sensation to return to the lips by 75 to 85 minutes—or by more than half the usual time. [2]

    OraVerse, the first dental anesthesia reversal agent on the market, received FDA approval May 9, 2008, for patients ages 6 and older and weighing more than 33 pounds. [3]

    Phentolamine mesylate, the drug in OraVerse, counteracts epinephrine, an additive in dental anesthesia that constricts blood vessels to keep blood from carrying the anesthetic away from the mouth too quickly. OraVerse offsets the effects of epinephrine by expanding blood vessels to accelerate blood flow and carry the anesthetic away, restoring full sensation to patients’ mouths. [4]  

    “We aren’t reversing the local anesthesia,” said Dr. Paul A. Moore, chairman of anesthesiology at the University of Pittsburgh School of Dental Medicine and an adviser to Novalar, the specialty pharmaceutical company that developed OraVerse. “It is reversing the epinephrine.” [5]

    OraVerse’s FDA approval is based on two Phase 3 studies in adults and adolescents ages 12 and older and a Phase 2 pediatric study. Trials excluded patients undergoing root canals or tooth extractions because they are expected to experience residual pain after the procedure and therefore should not receive OraVerse, Moore said. [6]

    While blindfolded, the patients in the trials were given either OraVerse or a fake injection. They then tapped their lips every five minutes for five hours to feel for sensation while observers measured the evenness of their smiles, checked for drooling and had the patients read sentences aloud. [7]

    The two randomized, double-blinded, controlled Phase 3 studies included 484 dental patients in 18 centers across the U.S., including private clinics, clinical research organizations and leading dental schools. Both Phase 3 studies showed a statistical difference between OraVerse and the control. [8]

    The multi-center, randomized, double-blinded, controlled Phase 2 pediatric study included 152 patients and found that the median time it took for full sensation to return to patients ages 6 to 11 was reduced by 75 minutes, demonstrating a 56-percent acceleration. [9]

    The drug will be particularly helpful for pediatric, elderly and special-needs patients, all of whom have tendencies to bite their lips or tongues while their mouths are numb. OraVerse will also allow patients to undergo procedures on both sides of their mouths during a single visit rather than requiring two separate dentist visits. [10]

    Dr. Athena Papas, professor at the Tufts University School of Dental Medicine, an adviser to Novalar and an investigator in clinical trials, said the drug would appeal especially to patients receiving cosmetic dentistry because they like to look good when they leave the dentist’s office. [11]  

    The idea for a drug like OraVerse came about when Eckard Weber, a partner in San Diego’s Domain Associates venture capital firm, visited his dentist, Dr. Howard Katz. Weber and Katz patented phentolamine mesylate for dental anesthesia reversal, and Weber created Novalar in 2001 to take the drug to market. [12]

    Novalar plans to launch OraVerse at the 2008 American Dental Association (ADA) Annual Session in San Antonio, Texas, Oct. 16-20. [13] At this time, the company expects OraVerse to cost between $5 and $25. [14] Novalar’s studies revealed interest in the product among both consumers and dentists, some of whom said they plan to mark up the price of the drug in order to increase profits. [15] About 300 million injections of local anesthesia are given annually in the U.S. [16]

     



    [1] Somers, Terri. Dental Anesthesia Reversal Drug OK’d. The San Diego Union-Tribune. May 10, 2008.

    [2] Pollack, Andrew. Drug Promises to Restore Sensation After Dental Visit. The New York Times. May 12, 2008.

    [3] Somers, Terri. Dental Anesthesia Reversal Drug OK’d. The San Diego Union-Tribune. May 10, 2008.

    [4] Pollack, Andrew. Drug Promises to Restore Sensation After Dental Visit. The New York Times. May 12, 2008.

    [5]  Ibid.

    [6]  Ibid.

    [7]  Ibid.

    [8]  Novalar Pharmaceuticals, Inc. Receives FDA Approval for OraVerse. FierceBiotech. May 12, 2008.

    [9]  Ibid.

    [10] Somers, Terri. Dental Anesthesia Reversal Drug OK’d. The San Diego Union-Tribune. May 10, 2008.

    [11] Pollack, Andrew. Drug Promises to Restore Sensation After Dental Visit. The New York Times. May 12, 2008.

    [12] Somers, Terri. Dental Anesthesia Reversal Drug OK’d. The San Diego Union-Tribune. May 10, 2008.

    [13]  Novalar Pharmaceuticals, Inc. Receives FDA Approval for OraVerse. FierceBiotech. May 12, 2008.

    [14] Somers, Terri. Dental Anesthesia Reversal Drug OK’d. The San Diego Union-Tribune. May 10, 2008.

    [15] Pollack, Andrew. Drug Promises to Restore Sensation After Dental Visit. The New York Times. May 12, 2008.

    [16] Somers, Terri. Dental Anesthesia Reversal Drug OK’d. The San Diego Union-Tribune. May 10, 2008.



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