New Study Shows Standard Therapy For Gum Disease is Significantly More Effective When Combined With Local Antibiotics

WARMINSTER, Pa.--(BUSINESS WIRE)--A new study published today in the Journal of Periodontology shows that a combination of the locally delivered antibiotic ARESTIN® (minocycline hydrochloride) Microspheres, 1mg, plus the standard treatment procedure for gum disease is significantly more effective than standard treatment alone in reducing the amount of surrounding tissue and bone that has been destroyed. The combination of ARESTIN® plus standard treatment effectively controls periodontal infection and creates a better environment where healing can occur.

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The study measured the antibacterial effectiveness of using ARESTIN® to treat the specific bacteria, also known as red complex bacteria, which have been shown to cause gum disease (periodontal disease). The study results show that when administered in conjunction with the standard treatment procedure, called scaling and root planning (SRP), ARESTIN® significantly reduced the proportion of these disease-causing bacteria by 29 percent more than SRP alone. Thirty days after treatment, patients treated with SRP alone had 43 percent more periodontal disease-causing bacteria than patients receiving treatment with ARESTIN®. Additionally, patients who received the locally delivered antibiotic maintained a level of bacteria comparable to that seen in healthy patients.

The study also found that ARESTIN® plus conventional therapy significantly decreased gum bleeding, which is a sign of reduced inflammation and a measurement of the health of the gums. The control of this inflammation helps create an environment that makes it harder for the periodontal pathogens to thrive and grow. When a combination of SRP and locally-delivered antibiotic treatment is used, bleeding gums are reduced by 79 percent, compared to conventional therapy alone.

"Our findings can have a significant impact on the way periodontal disease is treated," concluded Dr. J. Max Goodson, lead investigator for the study and senior member of the Department of Periodontology at the Forsyth Institute. "In addition, ARESTIN significantly reduced the tissue damage caused by periodontal disease to a greater extent than treatment by SRP alone. Based on risk/benefit analysis use of ARESTIN would be preferred because there is little or no added risk, and it provides a clear benefit."

Study authors were also excited to find that the anti-bacterial effect of locally-delivered ARESTIN® was highly specific and caused little impact on oral bacteria that are commonly found in healthy mouths. Treatment was directed almost entirely toward restriction of the bacteria that cause periodontitis, with little inhibitory effect on species thought to be beneficial.

What is Periodontal Disease?

Gum disease, also known as periodontal disease, affects more than 50 million adults across many demographic categories.(1) Advanced periodontal disease is marked by tender, swollen, and painful gums that bleed easily. After initial development of the disease, the gums may produce ulcers, which can then lead to cell death, resulting in tooth loss.(2)

What is Scaling and Root Planing?

SRP is an in-office procedure for patients with periodontal disease, during which a dental professional removes hard and soft deposits of calculus from the root surfaces of the teeth using mechanical or ultrasonic devices. This encourages healing and potential reduction in depth of the periodontal pocket, which is the space that forms at the gumline around teeth where bacteria can accumulate. This study showed 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 in addition to SRP. The ARESTIN® Microspheres are placed into the periodontal pockets, to which they adhere and deliver therapeutic drug concentrations for up to 21 days after administration.(3)

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); Francis Doherty (OraPharma, Inc.) ); and J. Comiskey (OraPharma, Inc.). The study was supported in part by a grant from OraPharma, Inc.

ARESTIN® (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® may be used as part of a periodontal maintenance program which includes good oral hygiene and scaling and root planing.

ARESTIN® 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 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® (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® 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® and OSSIX® 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® (minocycline hydrochloride) 1 mg Microspheres (Prescribing Information). Warminster, PA: OraPharma, Inc.; 2005

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