Fuisz Pharma Announces Availability of Objective REMS Criteria for Opioids
Joseph Fuisz, CEO of Fuisz Pharma LLC, stated: "Present REMS procedures look in substantial part to the Caregiver to discern whether the patient is (a) non-compliant, (b) an abuser, (c) a seller or diverter, or (d) a dependable, compliant patient. The present systems are non objective in nature and rely on the Caregiver to discern often vague visual and social cues for abuse, diversion and compliance.
"If the Caregiver is therefore unable to determine that abuse, diversion or compliance is occurring, we must rely on other protections such as various manufacturing techniques that may disable access to some of the active drug for the potential abuser. However, as is apparent to industry watchers, it is challenging to actually prove the efficacy of such protections, particularly in an environment where sophisticated abusers understand the protections and share work arounds, akin to computer hackers.
"This points to the criticality of further empowering the Caregiver to confirm compliance or discern abuse through readily confirmable and objective criteria, which at Fuisz is in our intellectual property portfolio comprising various pending Fuisz applications together with Gruber patent (7,214,385), owned by Fuisz. Simply put, this system allows the Caregiver to know if his patient is taking the drug. It allows the Caregiver to know if he has a seller as a patient. It allows the Caregiver to know he is looking at an abuser. It allows the Caregiver to know he has a compliant patient.
"By empowering Caregivers to strengthen their role in REMS, we expect a more confident prescribing physician who is operating for the first time with the benefit of objective criteria."
Noted pharmaceutical inventor Richard C. Fuisz, M.D. (http://en.wikipedia.org/wiki/Richard_Carl_Fuisz) is one of the principals of Fuisz Pharma.
Fuisz Pharma is a private pharmaceutical technology company originated by the Fuiszes. The Fuiszes have made substantial contributions in drug delivery including orally dissolving tablets and novel particle coating systems at Fuisz Technologies; inventing and developing thin film drug delivery technologies at Kosmos Pharma and MonoSol Rx, as well as independently developing extruded sheet technology, and have extensive experience working with big and specialty pharma. Fuisz Pharma has its headquarters in Miami. www.fuisz.com.
Fuisz LLC also has Fuiszreport.com which is an organically generated site for spontaneous comments by patients on drugs. www.fuiszreport.com
SOURCE Fuisz Pharma LLC