Expanded Access Policy

 

Novaremed is developing an investigational new drug, NRD.E1, a small, orally available molecule for the treatment of painful diabetic peripheral neuropathy (PDPN), which is currently in Phase 2 clinical development. A limited number of patients have been exposed to NRD.E1 at the present time.

The efficacy and appropriate conditions of use (e.g., dose regimen, patient population, drug-drug interactions) for NRD.E1 have not yet been confirmed and therefore Expanded Access is not considered at this phase of development. Novaremed considers it more appropriate to start an Expanded Access program only when long-term efficacy and tolerability of NRD.E1 have been demonstrated for chronic use.

As such Novaremed believes that participation in our future clinical trials is the most appropriate way to access our investigational therapy. Patients whose PDPN is not adequately managed with existing therapy and who therefore are seeking alternatives, especially investigational drug treatments, will be encouraged to participate in our upcoming NRD.E1 clinical studies. These studies will be posted on clinicaltrials.gov (and other trial registries as appropriate).

Novaremed will continue to assess the eligibility requirements and criteria for Expanded Access to the investigational drug NRD.E1 and will re-evaluate this policy on a yearly basis.