Peripheral neuropathy

EpiCept Corporation has filed a fast track designation with the US Food and Drug Administration (FDA) for its AmiKet, used for the treatment of chemotherapy-induced peripheral neuropathy (CIPN).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

AmiKet is a prescription topical analgesic cream comprises of amitriptyline 4% and ketamine 2%; it is currently under late stage clinical development by EpiCept for the treatment of peripheral neuropathic pain.

The company received finalised guidance from the FDA for the Phase III clinical and nonclinical development and subsequent new drug application (NDA) filing of AmiKet on 23 January 2012.

The proposed 12-week four-arm factorial-designed Phase III clinical programme in CIPN will demonstrate AmiKet’s superiority compared with a placebo, with each of the component drugs of AmiKet, amitriptyline and ketamine.

In several Phase II studies, AmiKet has reported considerable improvements in the treatment of pain from post-herpetic neuralgia compared with gabapentin in another placebo-controlled study.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In 2011, EpiCept announced positive results from a National Cancer Institute-sponsored study investigating the efficacy and safety of AmiKet in CIPN.

The fast track programme is intended to facilitate the development and accelerate the review of drugs designed to treat serious or life-threatening conditions, as well as address unmet medical needs.

According to the FDA, products with a fast track designation receive priority review, which may reduce the standard review time by half.

EpiCept is focused on the development and commercialisation of pharmaceutical products for the treatment of cancer and pain associated with peripheral neuropathies.

 

Image: Micrograph showing a vasculitic peripheral neuropathy. Photo: Nephron.