The list of FDA approved drugs for dentistry and maxillofacial surgery appears below. Click any link to view the full drug information.
Number Of Dental Drugs / Dentistry Drugs: 7
Aphthasol
Company: Block Drug Company
Approval Status: Approved December 1997
Treatment for: canker sores
Areas: Dental / Dentistry; Immune System
| General Information | Clinical Results |
General Information
A new prescription medication is now available to dentists and physicians to provide help to millions of canker sore sufferers in the U.S. Aphthasol (amlexanox oral paste, 5%), the first and only prescription medication indicated specifically for the treatment of canker sores, has been approved in patients with normal immune systems. Aphthasol is available in 5 gram tubes.
Clinical Results
Aphthasol was proven safe and effective when used as directed in four clinical trials with more than 1,300 patients. The most common adverse effects, as reported by 1-2% of patients, were transient pain, burning, and/or stinging sensations at the site of application. Clinical data confirms that best results from Aphthasol occur with earliest possible use.
Arestin (minocycline hydrochloride)
Company: OraPharma
Approval Status: Approved February 2001
Treatment for: Periodontal disease
Areas: Dental / Dentistry
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
Arestin (minocycline hydrochloride) is indicated for the adjunctive treatment of adult periodontitis following scaling and root planing, which consist of deep cleaning of the teeth and gums. It is painless to apply and is completely resorbed, leaving nothing to be removed. Arestin is highly bioadhesive, not requiring any retention dressings, and will not leak or fall out. The drug has been studied only in patients with chronic periodontitis.
Periodontal disease is a vastly under treated health problem that carries serious risks. It affects more than 50 million people in the United States, though less than one-fifth of these individuals receive treatment. Studies suggest a possible systemic link between periodontal disease and overall health, including conditions such as coronary heart disease, stroke, and diabetes.
Clinical Results
Clinical trials testing the safety and effectiveness of the product were conducted in over 900 subjects with chronic periodontitis. These landmark trials, conducted in 23 centers across the United States, involved tens of thousands of individual periodontal pockets. Treatment using Arestin following scaling and root planing significantly reduced pocket depth compared with scaling and root planing alone, even for the hardest to treat sites and with the most challenging patients.
Side Effects
Adverse events associated with the general use of minocycline may include (but are not limited to) the following:
Nausea or diarrhea
Dizziness
Sensitivity to sun
"Furry" or swollen tongue
Mechanism of Action
Arestin uses patented microsphere technology to deliver minocycline, a tetracycline antibiotic, beneath the gum, directly into the infected periodontal pocket.
Atridox
Company: Atrix Laboratories
Approval Status: Approved January 1999
Treatment for: Dental/Maxillofacial Surgery
Areas: Dental / Dentistry
Possible similar drugs: Atridox
| General Information | Clinical Results | Side Effects | Mechanism of Action |
General Information
AtridoxDOX is indicated for use in the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing.
The ATRIDOX product is a subgingival controlled-release product composed of a two syringe mixing system. Syringe A contains 450 mg of the ATRIGEL® Delivery System, which is a bioabsorbable, flowable polymeric formulation composed of 36.7% poly(DL-lactide) (PLA) dissolved in 63.3% N-methyl-2-pyrrolidone (NMP). Syringe B contains doxycycline hyclate which is equivalent to 42.5 mg doxycycline. The constituted product is a pale yellow to yellow viscous liquid with a concentration of 8.5% w/w of doxycycline.
Clinical Results
In two well-controlled, multicenter, parallel-design, nine-month clinical trials, 831 patients (Study 1=411; Study 2=420) with chronic adult periodontitis characterized by a mean probing depth of 5.9 to 6.0 mm were enrolled. Subjects received one of four treatments:
ATRIDOX
Scaling and Root Planing
Vehicle Control
Oral Hygiene
Treatment was administered to sites with probing depths 5 mm or greater that bled on probing. Subjects with detectable subgingival calculus on greater than 80% of all tooth surfaces were excluded from enrollment. All subjects received a second administration of the initially randomized treatment four months after their baseline treatment. Changes in the efficacy parameters, attachment level, pocket depth, and bleeding on probing, between baseline and month 9 showed that:
ATRIDOX was superior to Vehicle Control and Oral Hygiene
ATRIDOX met the decision rule of being at least 75% as good as Scaling and Root Planing (SRP) (the standard of at least 75% as good as SRP is required for any product approved as a stand alone therapy for periodontitis).
A single-center, single-blind, randomized, clinical study in 45 subjects with periodontal disease demonstrated that a single treatment with ATRIDOX resulted in the reduction in the numbers of P. gingivalis, P. intermedia, C. rectus, F. nucleatum, Bacteroides forsythus, and E. corrodens in subgingival plaque samples. Levels of aerobic and anaerobic bacteria were also reduced after treatment with ATRIDOX. The clinical significance of these findings, however, is not known. During these studies, no overgrowth of opportunistic organisms such as Gram-negative bacilli and yeast were observed. However, as with other antibiotic preparations, ATRIDOX therapy may result in the overgrowth of nonsusceptible organisms including fungi.
Clinicians should note that the studies were of nine months duration. Additional research would be necessary to establish long term comparability to SRP.
Side Effects
ATRIDOX should not be used in patients who are hypersensitive to doxycycline or any other drug in the tetracycline class.
In clinical trials involving a total of 1436 patients, adverse experiences were monitored across treatment groups.
In the Circulatory System category, 10 subjects (1.6%) in the ATRIDOX group were reported as having unspecified essential hypertension. Only 1 subject (0.2%) in the Vehicle group, and none in the Scaling and Root Planing or Oral Hygiene groups were reported to have unspecified essential hypertension. In all cases, the event occurred anywhere from 13 to 134 days post-treatment.
There is no known association of oral administration of doxycycline with essential hypertension.
Two patients in the polymer vehicle group and none in the ATRIDOX group (0.2% for both groups combined) reported adverse events consistent with a localized allergic response.
Sex, age, race and smoking status did not appear to be correlated with adverse events.
Mechanism of Action
Doxycycline is a broad-spectrum semisynthetic tetracycyline.1 Doxycycline is bacteriostatic, inhibiting bacterial protein synthesis due to disruption of transfer RNA and messenger RNA at ribosomal sites.
In vitro testing has shown that Porphyromonas gingivalis, Prevotella intermedia, Campylobacter rectus, and Fusobacterium nucleatum, which are associated with periodontal disease, are susceptible to doxycycline at concentrations <6.0 µg/mL.
Atridox
Company: Atrix Laboratories
Approval Status: Approved September 1998
Treatment for: Periodontal disease
Areas: Dental / Dentistry
Possible similar drugs: Atridox
| General Information |
General Information
Atridox comprises doxycycline in the Atrigel delivery system, which is administered as a gel and solidifies in situ.
DentiPatch (lidocaine transoral delivery system)
Company: Noven Pharmaceuticals
Approval Status: Approved May 1996
Treatment for: pain from oral injections, soft tissue dental procedures
Areas: Dental / Dentistry
| General Information | Clinical Results |
General Information
DentiPatch has been approved as a dental anesthetic patch for the prevention of pain from oral injections and soft-tissue dental procedures. The DentiPatch system is a small adhesive strip that contains lidocaine, the most frequently used anesthetic in dentistry.
Clinical Results
Clinical trials have demonstrated that the transoral patch effectively numbs the area covered by the patch in about two minutes, and remains effective for up to 45 minutes. DentiPatch was proven to be safe, with negligible systemic absorption of the anesthetic.
Periostat (doxycycline hyclate)
Company: CollaGenex Pharmaceuticals
Approval Status: Approved February 2001
Treatment for: Periodontal disease
Areas: Dental / Dentistry
Possible similar drugs: Periostat
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
Periostat is a twice daily, orally administered tablet that has been approved as an adjunctive treatment to scaling and root planing (SRP), a deep cleaning of the teeth and gums. This drug promotes attachment level gain and reduces pocket depth in patients with adult periodontitis. The capsule formulation of Periostat was approved for use in September 1998.
Periodontitis is the most serious of the periodontal diseases, commonly referred to as gum diseases. It is remarkably common in adults over the age of 35, with some sources estimating that up to one third of American adults suffer from some form of periodontitis. The etiology of periodontitis is multifactorial. Its nature and severity are determined by complex interactions between infectious bacteria and a susceptible host. The end results of this interaction are the bone and soft tissue destruction and attachment loss that characterize periodontitis.
Current first-line therapies for periodontitis, such as SRP, primarily address the bacterial component of the disease. If indicated, SRP may be supplemented by antimicrobial drugs. Periostat is the first and only drug designed to reduce the activity of the enzymes that destroy tooth and gum tissue. When prescribed as an adjunct to SRP, it has been shown to help slow the progression of adult periodontitis more effectively than SRP alone.
Clinical Results
The efficacy of Periostat (doxycycline hyclate) as an adjunctive treatment for adult periodontitis was established in a randomized, multi-center, double-blind, nine month phase III study involving 190 subjects with periodontal disease. The effects of oral administration of twice daily Periostat tablets in combination with SRP procedures were compared to placebo plus SRP.
Results were based on measurements of pocket depth, attachment level, and bleeding-on-probing. Such measurements were obtained from the treated areas directly after SRP, after three months, six months, and nine months. Periostat administered with SRP improved clinical attachment level by up to 52 percent and reduced pocket depth by as much as 67 percent compared to SRP plus placebo. These benefits were observed as early as three months into the study and were maintained over the nine month period of the trial.
Side Effects
Adverse events associated with the use of doxycycline hyclate may include (but are not limited to) the following:
Diarrhea
Heartburn
Joint pain
Nausea
Mechanism of Action
Periostat (doxycycline hyclate) is an oral enzyme inhibitor that works by reducing the activity of host-derived enzymes, such as collagenase. Collagenase has been shown to be associated with the destruction of the periodontal support structures during the progression of adult periodontitis. Periostat is administered systemically, offering the additional advantage of being able to treat all the tooth sites simultaneously, a whole-mouth approach to the management of the host response.
Periostat (doxycycline hyclate)
Company: CollaGenex Pharmaceuticals
Approval Status: Approved October 1998
Treatment for: Dental
Areas: Dental / Dentistry
Possible similar drugs: Periostat
| General Information | Side Effects | Mechanism of Action | Literature References |
General Information
Periostat is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.
Side Effects
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Mechanism of Action
Doxycycline has been shown to inhibit collagenase activity in vitro. Additional studies have shown that doxycycline reduces the elevated collagenase activity in the gingival crevicular fluid of patients with adultperiodontitis. The clinical significance of these findings is not known.
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