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The web links in this directory are public information provided to the Foundation and the acknowledgement times listed are the number of days or hours for a company to acknowledge receipt of request, not to make a decision. Data contained in this directory is provided either directly by the company or by ClinicalTrials.gov for the companies listed in this directory.
The Expanded Access listings provided on this website are limited to those companies currently in the Company Directory and include listings for expanded access which are Available, Temporarily Not Available and Approved for Marketing, which in some cases includes treatments which have not yet reached the market. In addition, many companies are willing to consider expanded access requests even if they do not show active Expanded Access Listings in this directory. Contact the company to explore the possibility of individual access to an investigational therapy.
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WEX Pharmaceuticals Inc.
Expected Application Timeframe
5 Business DaysSingle-Patient EA Policies/Criteria
An Early Access program for Halneuron may be opened if WEX determines that all of 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.
Available Therapies via Single-Patient EA
1. Moderate-to-severe chemotherapy-induced neuropathic pain
2. Post-burn pain
3. Post-burn itch
4. Chronic pain