New Periodontal Disease Study Shows SRP is Significantly More Effective With Local Antibiotics.

ARESTIN([R]) +SRP Therapy Creates Environment Conducive to Healing: Reduces Pocket Depth by Decreasing Perio Pathogens and Increases Attachment Level With Almost Twice the Effect on Bleeding

WARMINSTER, Pa. -- A new study published this month in the Journal of Periodontology shows that a combination of ARESTIN([R])(minocycline hydrochloride) Microspheres 1 mg, plus scaling and root planing (SRP) is significantly more effective than SRP alone in controlling periodontal disease. Study results indicate clearly that when ARESTIN([R]) is placed at the time of initial SRP, clinical markers of disease are reduced, such as pocket depth, inflammation, and bleeding on probing, thus creating an environment where healing has occurred.

The study measured the antimicrobial effectiveness of using ARESTIN([R]) to treat periodontal pathogens, also called red complex bacteria (RCB) (Porphyromonas gingivalis, Tannerella forsynthensis, and Treponema denticola), that play a primary role in periodontal infection. When administered in conjunction with SRP, ARESTIN([R]) significantly reduced the proportion of these disease-causing bacteria by 29percent more than SRP alone and showed nearly twice the reduction in levels of these periodontal pathogens. Additionally, ARESTIN([R]) patients maintained relative levels of periodontal pathogens normally seen in healthy patients, while the SRP only patients did not.

ARESTIN([R])plus SRP also significantly decreased pocket bleeding by 79 percent, more than SRP alone. From a microbiologic standpoint, reduction in pocket bleeding is a measure of reduced inflammation and reduced nutrient flow. This restriction of nutrients makes the environment less favorable for the re-growth of these periodontal pathogens.

Additionally, the study found that the combination of ARESTIN([R])and SRP led to positive changes in clinical attachment level (CAL) and overall reduction of periodontal disease. The mean gain in CAL for subjects receiving both treatments was 45 percent greater than in those treated with PDR alone (1.16 mm as opposed to 0.80 mm, respectively). Regarding pocket depth reduction (PDR), subjects treated with ARESTIN([R])and SRP experienced average reductions that were 37 percent greater than those observed in SRP-only groups (1.38 mm vs 1.01 mm, respectively). These findings suggest that the combination of ARESTIN and SRP is more effective in targeting bacteria that grow to a greater density in deeper pockets, such as the red complex strain, than SRP alone.

Study authors were excited to find that the anti-microbial effect of locally delivered ARESTIN([R]) were directed primarily at the periodontal pathogens and caused little impact on healthy or normally occurring oral bacteria.

"It is now recognized that chronic periodontitis is an infectious disease in which red complex bacteria play a primary role," said Dr. J. Max Goodson, lead investigator for the study and senior member of the Department of Periodontology at the Forsyth Institute. "This study supports a very strong association between these periodontal pathogens and periodontal disease and demonstrates that local antimicrobial therapy using ARESTIN([R]) and SRP effectively reduces the numbers of these periodontal pathogens and their proportions to a far greater extent than SRP alone. The result of this reduction allows for improved clinical outcomes for patients treated with ARESTIN plus SRP."

Dr. Goodson added, "Study authors concluded locally delivered ARESTIN exhibited surprising specificity of action in being directed almost entirely toward inhibition of bacteria generally considered periodontal pathogens with little inhibitory effect on other species. Based on risk/benefit analysis it would seem that regular use of ARESTIN would be preferred because there is little or no risk, and it provides a clear benefit."

About the Study

The study, titled "Minocycline HCI Microspheres reduce red-complex bacteria in periodontal disease therapy," is a phase IV, multi-center, single-blind, randomized, parallel-group trial. DNA probe analysis for 40 bacteria was used to evaluate 127 patients with moderate-to-advanced chronic periodontitis. The study's authors include: J. Max Goodson, (Forsyth Institute); John C. Gunsolley (Virginia Commonwealth University); Sara G. Grossi (East Carolina University); Paul S. Bland (University of Tennessee); Joan Otomo-Corgel (University of California-Los Angeles School of Dentistry); and Fergus Doherty (University Medical School, Queens Medical Centre, Nottingham, UK); and J. Comiskey (OraPharma, Inc). The study was supported in part by a grant from OraPharma, Inc.

ARESTIN([R]) (minocycline hydrochloride) Microspheres, 1 mg is indicated as an adjunct to scaling and root planing (SRP) procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN([R]) may be used as part of a periodontal maintenance program which includes good oral hygiene and scaling and root planing.

ARESTIN([R]) contains minocycline, a tetracycline derivative, and therefore should not be used in children and in pregnant or nursing women. The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of the teeth.

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.

About OraPharma, Inc.

OraPharma, Inc. is a specialty oral healthcare company that discovers, develops, and commercializes products that maintain and restore oral health. ARESTIN([R]) (minocycline hydrochloride) Microspheres, 1 mg (www.arestin.com) is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. OSSIX([R]) PLUS (resorbable collagen membrane) is used in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. For more information about OraPharma and its products, visit www.orapharma.com.

ARESTIN([R] )and OSSIX([R]) PLUS are registered trademarks of OraPharma, Inc., and IMPEDE([TM]) is a trademark of OraPharma, Inc.

References:

1. Albandar JM, Brunelle JA, Kingman A. Destructive periodontal disease in adults 30 years of age and older in the United States, 1988-1994. J Periodontol 1999;70:13-29.

2. American Academy of Periodontology. Periodontal (gum) diseases. Available at: www.perio.org/consumer/2a.html. Accessed February 27, 2006.

3. ARESTIN([R]) (minocycline hydrochloride) 1 mg Microspheres [Prescribing Information]. Warminster, PA: OraPharma, Inc.; 2005