US WorldMeds is committed to the future

In Development

US WorldMeds is committed to improving the lives of our patients, both in the products that we market and in the therapies that are currently under development. This commitment can be seen in our pipeline, where we are diligently working to bring new therapies and new indications to patients across multiple therapeutic areas.

Phases 1 2 3 R 4
Apomorphine Infusion
Idiopathic Parkinson's disease
Lofexidine
Opioid withdrawal symptoms
Melphalan
Multiple myeloma
RimabotulinumtoxinB
Sialorrhea
R = Registration

Ongoing Clinical Trials

Clinical trials are the cornerstone of furthering our mission to improving the lives of patients. US WorldMeds is committed to sponsoring safe and effective trials that help to better the lives of patients.

Drug
Apomorphine Infusion
Condition
Idiopathic Parkinson’s Disease
Phase
3
Study Title
Infusion of Apomorphine: Long-term Safety Study (INFUS-ON)
Link

Expanded Access Policy

US WorldMeds is committed to serving patients by providing safe, fair, and sustainable patient access to its medicines. US WorldMeds may be able to provide patients access to its investigational drugs outside of a clinical trial if certain conditions are met and if permitted by local law and regulation. The use of an investigational medical product (i.e., one that has not been approved by the Food and Drug Administration [FDA]) outside of a clinical trial is known as Expanded Access (sometimes referred to as “compassionate use”). Expanded Access may not always be available and requires the individual patient to meet certain eligibility conditions as outlined below:

  • The patient has a serious or life-threatening illness
  • Both the patient and his or her licensed physician are willing to participate
  • The patient’s physician determines there is no comparable or satisfactory therapy available to diagnose, monitor, or treat the patient’s disease or condition
  • The probable risk to the patient from the investigational product is not greater than the probable risk from the disease or condition
  • FDA determines there is sufficient evidence of the safety and effectiveness of the investigational product to support its use in the particular circumstance
  • FDA determines that providing the investigational product will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval
  • The sponsor or the clinical investigator submits a clinical protocol that is consistent with FDA’s statute and applicable regulations for Investigational New Drugs (IND) or Investigational Device Exemption (IDE), describing the use of the investigational product
  • The patient is unable to obtain the investigational drug under another IND or to participate in a clinical trial

Generally, there are two types of Expanded Access—Group Expanded Access and Individual Patient Expanded Access. Currently, US WorldMeds offers Individual Patient Expanded Access. Individual patient access is managed by the patient’s physician. For a patient to receive an investigational product through Individual Patient Expanded Access, his or her physician must submit a request to the FDA on behalf of his or her patient.

US WorldMeds currently does not offer any Group Expanded Access programs. In the event US WorldMeds begins accepting requests for Group Expanded Access, this website and policy will be updated with a hyperlink or other reference to the Expanded Access record on clinicaltrials.gov.

For more information on the different types of Expanded Access, click here.

Physicians may also contact US WorldMeds with questions regarding Expanded Access at request@usworldmeds.com. US WorldMeds employs a team of medical professionals who are familiar with the investigational drugs available, and can help physicians through the Expanded Access application process. US WorldMeds anticipates that it will respond within five (5) business days of receipt of the communication.

In line with the 21st Century Cures Act, US WorldMeds cannot guarantee access to our investigational products to all patients. US WorldMeds may revise this policy at any time; at such time, the website and policy will be updated accordingly.