Product
Akten
Approval Date
Oct. 7, 2008
Release Date
Oct. 2008
Company
Akorn, Inc.
Class
Local anesthetic
Indication
Ocular surface anesthesia during ophthalmologic procedures.
Active Ingredient
Lidocaine Hydrochloride 3.5%; ophthalmic gel; preservative-free.
Agency Roster
Internal
Marketing Strategy/Execution
Akten is suited for ophthalmic procedures in both hospitaland office based surgical settings such as cataract surgery, refractivesurgery, Lasik surgery, and intravitreal injection. Akten will be manufacturedat Akorn’s Somerset, NJ facility and will be marketed directly tohospitals and ophthalmologists with a targeted detail sales effort, by our 65sales representatives.
Also in the Pipeline(courtesy of Adis R&D Insight)
No competitor compounds in phase III or pre-registration, US.
Pharmacology
Akten is a local anesthetic agent that stabilizes theneuronal membrane by inhibiting the ionic fluxes required for the initiationand conduction of impulses, thereby effecting local anesthetic action.Anesthesia generally occurs between 20 seconds to 1 minute and lasts for 5 to30 minutes.
Clinical Trials
A total of 209 patients in a double-blind study wererandomized to receive either Akten 1.5%, Akten 2.5%, Akten 3.5%, or sham. Inthis trial, 92% of the Akten 3.5% group achieved ocular anesthesia within 5minutes of application. The mean time to anesthesia onset was 60 seconds. Theduration of anesthesia ranged from 5 to 30 minutes with a mean time of 15minutes for the Akten 3.5% group. The anesthetic effect of additionalapplications of Akten has not been evaluated.
Adverse Reactions
Conjunctival hyperemia, corneal epithelial changes, headache,burning upon instillation.
Adults and Children
For single patient use. 2 drops to the ocular surface inarea of planned procedure; may reapply as needed.
Precautions
Not for injection. Prolonged use may cause cornealopacification. Pregnancy (Cat. B).
