Expanded Access Policy

Scilex Holding Company (Scilex) is dedicated to the development and commercialization of non-opioid pain management products using innovative delivery technologies and is actively evaluating the safety and effectiveness of these therapies.

Expanded Access Policy

The US Food and Drug Administration (FDA) has established criteria for the provision of investigational medicines* to patients outside of clinical trials (compassionate use/expanded access).  That guidance provides that expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medicine for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available1.

Expanded access may be appropriate when the following factors have been considered2:

  • Patient has a serious or life-threatening illness or condition and is not responsive to or able to tolerate any available treatment option
  • The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition
  • Patient enrollment in a clinical trial is not possible
  • Potential patient benefit justifies the potential risks of treatment
  • Providing the investigational medicine will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational medicine for broader patient access
  • Adequate supply of the investigational medicine is available

Currently, Scilex is not accepting applications for expanded access of our investigational medicines.  Our development resources are focused on conducting clinical trials that evaluate the safety and effectiveness of our investigational medicines for treating acute and chronic pain. Our clinical trial programs are the primary way to gain access to a Scilex investigational medicine and Scilex encourages patients to speak with their treating physicians about participating in a clinical trial whenever possible.

Scilex may reconsider making its investigational medicines available through an Expanded Access Program in the future as we continually evaluate each of our investigational medicines for appropriateness of expanded access based on FDA’s established criteria. 

Healthcare providers, patients and caregivers interested in learning more about Scilex’s investigational therapies should contact Scilex at [email protected]

Additional information regarding our clinical trials may be accessed on www.clinicaltrials.gov.

*This policy is subject to change.  Scilex may revise this policy at any time and may establish different expanded access policies for each investigational medicine under development.  The posting of this policy by Scilex shall not serve as a guarantee of access to any specific investigational medicine by any individual patient. 

**Investigational medicines have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medicine may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.

References:

  1. https://www.fda.gov/news-events/public-health-focus/expanded-access (accessed September 1, 2022); see also 21 C.F.R. 312.305(a)
  2. https://navigator.reaganudall.org/companies-and-sponsors#introduction (accessed September 1, 2022)