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Clinical Trials

FDA Approved Drugs » 2008
Medical Areas: Ophthalmology | Pharmacology/Toxicology

View By:Year | Company | Conditions | Therapeutic Areas | Drug Names

Akten (lidocaine hydrochloride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Akorn
Approval Status: Approved October 2008
Treatment Area: anesthesia during ophthalmologic procedures

General Information

Akten is a gel formulation of the local anesthetic agent lidocaine. Akten stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Anesthesia generally occurs between 20 seconds to 1 minute and persists for 5 to 30 minutes.

Akten is specifically indicated as a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures.

Akten is supplied as an ophthalmic gel (3.5%) containing 35 mg per mL of lidocaine hydrochloride designed for topical ophthalmic administration. The recommended initial dose of the drug is two drops applied to the ocular surface in the area of the planned procedure. Akten may be reapplied to maintain anesthetic effect.

Clinical Results

FDA Approval
FDA approval of Akten was based the results of a multi-center, randomized, controlled, double-blind study. This study enrolled 209 subjects who received placebo or Akten 1.5%, 2.5% or 3.5%. Ocular anesthesia was achieved within five minutes of anesthetic application by 47 of 51 subjects (92%) in the Akten 3.5% group. The mean time to anesthesia onset ranged from 20 seconds to 5 minutes and was not affected by Akten dose. The mean time to anesthesia onset was approximately 60 seconds, with a median onset time of 40 seconds for the Akten 3.5% group. Among the subjects in the Akten groups who achieved anesthesia within 5 minutes, approximately 90% had achieved anesthesia within 60 seconds of application. The duration of anesthesia generally ranged from approximately 5 minutes to 30 minutes, with mean anesthesia durations of approximately 15 minutes for the Akten 3.5% group. Approximately 84% of the subjects in the Akten 3.5% group experienced anesthesia for at least 5 minutes, approximately 55% of subjects experienced anesthesia for 10 minutes or longer and 27% experienced anesthesia for 15 minutes or longer.

Side Effects

Adverse events associated with the use of Akten may include, but are not limited to, the following:

  • Conjunctival hyperemia
  • Corneal epithelial changes
  • Headache
  • Burning upon instillation

Mechanism of Action

Akten is a gel formulation of the local anesthetic agent lidocaine. Akten stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Anesthesia generally occurs between 20 seconds to 1 minute and persists for 5 to 30 minutes.

Literature References

Busbee BG, Alam A, Reichel E Lidocaine hydrochloride gel for ocular anesthesia: results of a prospective, randomized study. Ophthalmic Surgery, Lasers & Imaging : the official journal of the International Society for Imaging in the Eye 2008 Sep-Oct;39(5):386-90

Amiel H, Koch PS Tetracaine hydrochloride 0.5% versus lidocaine 2% jelly as a topical anesthetic agent in cataract surgery: comparative clinical trial. Journal of Cataract and Refractive Surgery 2007 Jan;33(1):98-100

Bardocci A, Lofoco G, Perdicaro S, Ciucci F, Manna L Lidocaine 2% gel versus lidocaine 4% unpreserved drops for topical anesthesia in cataract surgery: a randomized controlled trial. Ophthalmology 2003 Jan;110(1):144-9

Barequet IS, Soriano ES, Green WR, O'Brien TP Provision of anesthesia with single application of lidocaine 2% gel. Journal of Cataract and Refractive Surgery 1999 May;25(5):626-31

Additional Information

For additional information regarding Akten or ophthalmologic anesthesia, please visit the Akten web page.