SOURCE: OraPharma, Inc.

March 07, 2006 15:00 ET

New Study Confirms ARESTIN® + SRP More Effective Than SRP Alone in Eliminating Periodontal Pathogens

ARESTIN® Shown to Significantly Reduce Bacteria Responsible for Periodontal Disease

WARMINSTER, PA -- (MARKET WIRE) -- March 7, 2006 -- A new study highlighting the antimicrobial effectiveness of ARESTIN® (minocycline hydrochloride) 1 mg Microspheres in the treatment of periodontal disease will be presented at the first joint annual session of the American Dental Education Association (ADEA) and the American Association for Dental Research (AADR), March 8-11, 2006 in Orlando, Florida.

The study reveals a significant reduction in Red Complex Bacteria among patients with periodontal disease who were treated with ARESTIN® plus scaling and root planing (SRP) compared with patients who were treated with SRP alone. In addition, the study shows that ARESTIN® + SRP is more effective than SRP alone in:

--  Reducing periodontal pocket depth
--  Reducing bleeding on probing
--  Increasing clinical attachment level
--  Reducing periodontal pocket depth and bleeding on probing in smokers
    
Red Complex Bacteria (RCB) includes three pathogens associated with microbial infection in people with periodontal disease: Porphyromonas gingivalis, Tannerella forsythensis and Treponema denticola. More than 50 million adults across many demographic categories are affected by periodontal disease.(1) Advanced periodontal disease is marked by tender, swollen and painful gums that bleed easily. After initial development of the disease, the gums may ulcerate and then become necrotic, leading to tooth loss.(2)

Scaling and Root Planing (SRP) is the removal of hard and soft deposits from the root surfaces of the teeth using mechanical or ultrasonic devices, thereby permitting healing and potential reduction in depth of the periodontal pocket, which is the space that forms at the gum line around teeth. The study, to be presented at the joint ADEA and AADR annual session, shows that, in comparison to SRP alone, a statistically significant reduction in the numbers of infection-causing Red Complex Bacteria is achieved when ARESTIN® is administered as an adjunct to SRP. The ARESTIN® Microspheres are placed into the periodontal pockets, to which they adhere and deliver therapeutic drug concentrations for up to 14 days after administration.(3)

"We know that scaling and root planing is effective for gross removal of bacterial plaque and calculus in patients with periodontal disease," states Dr. J. Max Goodson, Senior Member of the Staff and Director of Clinical Research at The Forsyth Institute. "These studies, however, are important because they demonstrate that when SRP was followed by administration of ARESTIN®, there was a significant added reduction in bacteria that are thought to cause periodontal disease. Hence, the inclusion of ARESTIN® with mechanical treatment more effectively controlled these bacteria and created a measurably better clinical outcome."

About the Study:

The study, titled "Effect of Adjunctive Treatment with ARESTIN® on the Subgingival Microflora in Patients with Moderate to Advanced Periodontitis," is a phase IV, multicenter, single-blind, randomized, parallel-group study of 127 patients. The study will be presented by its authors as follows:

--  Lead Investigator Dr. J. Max Goodson, Senior Member of the Department
    of Periodontology at The Forsyth Institute, will discuss the "Antimicrobial
    Efficacy of ARESTIN® in Periodontitis Therapy." This discussion will
    cover data from this study on the use of ARESTIN® plus SRP and its
    ability to reduce numbers and proportions of Red Complex Bacteria to a
    significantly greater degree than SRP alone. This data indicates that the
    antimicrobial effect of ARESTIN® plus SRP exceeded that of SRP alone.
    
--  Principal Investigator Dr. John C. Gunsolley, Assistant Professor,
    Department of Periodontics at the University of Maryland Dental School,
    will discuss, "Association between the Antimicrobial and Clinical Finding
    with ARESTIN®" when used as an adjunct to SRP.
    
--  Dr. Paul S. Bland, Assistant Professor at the University of Tennessee
    Health Science Center, also a Principal Investigator for this study, will
    discuss "Clinical Efficacy and Safety with ARESTIN® in Patients with
    Periodontitis." The objective of his presentation is to discuss ARESTIN®
    plus SRP's efficacy vs. SRP alone in reducing periodontal pocket depths,
    decreasing the number of periodontal pockets =5mm, decreasing Bleeding on
    Probing (a key clinical indicator of disease presence) and increasing the
    clinical attachment level, or CAL. He will also confirm the therapeutic
    safety of ARESTIN®.
    
--  Dr. Sara G. Grossi, Senior Research Scientist at East Carolina
    University, and Principal Investigator for this study, is presenting a
    "Subset Analysis by Smoking Status with ARESTIN® in Periodontitis
    Therapy." The objective of this presentation is to analyze the
    antimicrobial and clinical effects of ARESTIN® as an adjunct to SRP in
    relation to smoking status. ARESTIN® plus SRP significantly reduced RCB
    numbers in current smokers. In addition, ARESTIN plus SRP resulted in
    greater periodontal pocket depth reduction and decreased bleeding on
    probing compared with SRP alone regardless of smoking status.
    

The important findings and results of each of these clinical studies will be presented in their entirety at the first joint annual session of the American Dental Education Association (ADEA) and the American Association for Dental Research (AADR), March 8 -11, 2006 in Orlando, Florida. For presentation times and room/booth locations, contact John Lenart, Senior Product Manager, OraPharma at Jlenart@cpcus.jnj.com.

About OraPharma, Inc.

OraPharma, Inc., is a specialty pharmaceutical company that discovers, develops and commercializes therapeutics for oral health. OraPharma is dedicated to the dental community, specifically the periodontal space, with its lead product, ARESTIN ® (minocycline hydrochloride) 1 mg Microspheres.

ARESTIN® is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN® may be used as part of a periodontal maintenance program which includes good oral hygiene, scaling and root planing.

The most common treatment-emergent adverse events were headache (9.0%), infection (7.6%), flu syndrome (5.0%), and pain (4.3%). These occurred at a similar rate to SRP and SRP + placebo. For additional product information, visit www.arestin.com.

In addition to ARESTIN®, OraPharma also distributes Oraqix® (lidocaine and prilocaine periodontal gel) 2.5% / 2.5%, a new sub-gingival local anesthetic periodontal gel indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing, and is manufactured by Dentsply Pharmaceuticals. For more information, visit www.orapharma.com.

References:

1. Albander JM, Brunelle JA, Kingman A. Destructive Periodontal Disease in Adults 30 Years of Age and Older in the United States, 1984-1994. J Periodontal 1999; 70:13-29. Accessed on February 27, 2006 at: http://www.perio.org/consumer/disease_facts.htm.

2. American Academy of Periodontology. Periodontal (Gum) Diseases. Accessed on February 27, 2006 at: http://www.perio.org/consumer/2a.html.

3. ARESTIN® Prescribing Information. OraPharma, Inc. Warminster, PA, 2005.

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