Amiket (amitriptyline/ketamine) / Immune Pharma - LARVOL DELTA

Amitriptyline and FDA Treatments for Fibromyalgia (RheumNow) - "Albeit unapproved, and off-label, amitriptyline is frequently used as is an established FM medication. Newer agents, such as pregabalin, duloxetine, and milnacipran are approved by the US Food and Drug Administration (FDA) for use in FM. Using data from 36 studies published between 2018 and 2020, RCT data was extracted and analyzed and subjected to a random-effects bayesian network meta-analysis (NMA)."

Online posting

[VIRTUAL] Isoniazid-associated Peripheral Neuropathy in a “Slow Acetylator”: Need for Pharmacogenomics in Tuberculosis treatment? (AAN 2021) - "Isoniazid was stopped, and the patient’s pain was managed with duloxetine, gabapentin, and topical amitriptyline-ketamine cream. This case highlights the potential implications of NAT2 pharmacogenomics testing prior to treatment of latent tuberculosis within the US. Prior knowledge of this patient’s genotype preceding and during therapy may have led to drug-level monitoring and prevention of her painful polyneuropathy. Others have demonstrated elevated risk of organ damage in “slow acetylator” NAT2 genotypes, including polyneuropathy, in other populations where tuberculosis is more common."

Biomarker • CNS Disorders • Pain • NAT2

“I have been to a pain specialist who has prescribed amitriptyline and lyrica together…dosage goes up there really is no difference in my condition.” (Baldingblog)

Drug combination

A case of erythromelalgia with a previously unclassified missense mutation of the SCN9A gene (BAD 2017) - "Neuromolecular Med 2013; 15: 265–78). We present this case as a novel missense mutation and for discussion of treatment options."

Biomarker • Clinical • HEOR • Biosimilar • Ophthalmology • Pain

Topical ketamine-amitriptyline-lidocaine for chronic pruritus: A retrospective study assessing efficacy and tolerability. (PubMed) - No abstract available.

Journal • Biosimilar

EpiCept transfers Ceplene responsibilities in European Union and sells license rights to Meda (Businesswire) - Liquidity resulting from this deal to fuel company's operations and capability to attract and finalize potential acquirers, investors or licensors for Amiket

Licensing agreement • Pain

“I don't take any meds - was on amitriptyline for over a year but it made me groggy - don't need that in addition to the fibro fog.” (Forums.webmd.com)

“Amitriptyline - for it to help the pain took two weeks for me. I am no longer needing this as my pain has improved with the meds I am on now” (The Lupus Site)

Epicept Corporation receives FDA permission to initiate Amiket phase III clinical development (Businesswire) - Company received permission from FDA to initiate P3 trial immediately; The FDA indicated that a chemotherapy-induced peripheral neuropathy (CIPN) treatment protocol submitted by Epicept will be reviewed expeditiously for a Special Protocol Assessment (SPA); The Company has submitted its draft meeting minutes for FDA concurrence and upon receipt of the FDA official meeting minutes will provide more details regarding the clinical and non-clinical package required prior to an NDA filing

Anticipated P3 study • Regulatory update • Pain

Epicept files for Amiket Fast Track Designation (Businesswire) - Epicept Corporation announced that it has filed for Fast Track Designation for Amiket (amitriptyline 4%, ketamine 2% cream) for the treatment for chemotherapy-induced peripheral neuropathy; EpiCept intends to submit the protocol for this trial to the FDA via a Special Protocol Assessment (SPA); An additional two-arm efficacy study in another painful peripheral neuropathy may be performed as an alternative strategy to a second factorial-designed trial for the NDA filing

Anticipated additional studies • Anticipated SPA discussion • Regulatory update • Pain