Expanded Access Policy
Introduction
WEX Pharmaceuticals Inc. (“WEX”) is a phase II /III clinical stage biopharmaceutical company committed to developing a new class of non-opioid analgesics. WEX’s proprietary platform and the lead product is Halneuron®. The active pharmaceutical ingredient in Halneuron is Tetrodotoxin (TTX) is a sodium channel blocker known to have analgesic effects with clinical signs of efficacy.
Halneuron is in late-stage clinical development for the treatment of moderate-to-severe chemotherapy-induced neuropathic pain, which is a high unmet medical need.
We are a science-driven company committed to putting patients first. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients.
Clinical trials and the subsequent timely generation of safety and efficacy data are the most effective way of ensuring review and decision making by Regulatory Authorities. This ultimately has resulted in access to new, safe and effective approved medicines for all patients.
Expanded access Compassionate Use refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.
Expanded access / Compassionate Use Criteria (Early Access)
An Early Access program for Halneuron may be opened if WEX determines that all the following criteria are met:
- The disease or condition is seriously debilitating or serious.
- The investigational drug is the subject of an active clinical development program and is not approved in any indication in the country concerned
- The patient is not eligible to participate in a suitable clinical trial
- An adequate supply of the investigational drug exists to perform necessary clinical studies as well as to provide Early Access to patients who do not have alternative treatment options
- There is adequate available data to permit selection of an appropriate dose level
- Early Access does not impede or compromise the clinical development or regulatory approval of the drug under investigation
- There are sufficient clinical data available with respect to both the investigational drug and the disease condition for which the application is being sought, to anticipate that any potential benefits from treatment are likely to outweigh any potential risks to the patient
- The patient, treating physician, regulatory authority and the company agree to the use of Halneuron
- Supplied drug is used as clinically indicated from the product information supplied by Halneuron and in discussion with the treating physician
Disclaimer
An existing program does not guarantee availability in all countries. Various regulatory mechanisms exist in different countries to provide Early Access to new medicines and as a result, country specific variations for Early Access will occur. Any Early Access to medicines must always comply with the applicable country-specific laws and regulations including medicines importation requirements.
- Statement: At this time, WEX believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. WEX continues to assess the eligibility requirements and criteria for Early Access to the investigational drug Halneuron and will re-evaluate this policy from time to time.
- Learn more: If you are a patient who is interested in accessing our investigational drugs, please speak with your physician. If you have additional questions, please contact wex@wexpharma.com.You may also learn more about ongoing clinical trials by going to www.clinicaltrials.gov and searching for Halneuron.
If you are a physician who is interested in learning more about our investigational drugs or participating in our clinical trials, please submit a request to wex@wexpharma.com.
It’s important to remember that Halneuron has not yet received regulatory approval; therefore, its potential risks and benefits are not yet established. Doctors and patients should consider all possible benefits and risks when seeking expanded access to the investigational drug Halneuron.
Please feel free to contact us with any questions.
WEX Pharmaceuticals Inc.
Suite 1150 – 1100 Melville Street
Vancouver, BC, Canada V6E 4A6
604-683-8880
604-683-8868
wex@wexpharma.com