D-PLEX, a new formulation of Doxycycline for local administration that is intended for prevention of Surgical Site Infections (SSIs) post cardiac surgery with median sternotomy and post abdominal surgery.
There are seriously ill patients who will not be eligible for our clinical trials and may be in a high risk to experience an infection post a surgical intervention. In these circumstances, POLYPID will consider providing the requesting surgeon with pre-approved access to D-PLEX, for the prevention of infection of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:
• The patient is scheduled for an abdominal or a median sternotomy surgery for any reason;
• The patient is not eligible to participate in POLYPID clinical trials;
• The patient has a serious or life-threatening illness or condition and his/her likelihood to develop a serious infection due to surgical intervention is high;
• The patient has a disease or condition for which there is sufficient evidence of a projected benefit from the use of the D-PLEX and the benefit outweighs the known or anticipated risks;
• A benefit-risk analysis, based on both the available clinical data as well as the requesting surgeon’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or a regulatory review or an approval of the investigational drug for broader patient access; and
• Adequate supply of the investigational drug is available and can be supplied in the appropriate timeline of request.