The side effects include CIPN
, pain, sleeplessness, nausea and depression.
The data suggest that acupuncture has a positive effect on CIPN
, as measured by objective parameters [nerve conduction studies]," said authors.
Oncology nurses often may be required to measure the presence or severity of CIPN
in patients with cancer so that steps can be taken to prevent' minimize' or reverse this distressing side effect and avoid treatment interruptions or delays.
The chemotherapeutic agents most often associated with CIPN
are platinum compounds, taxanes, vinca alkaloids, thalidomide, and bortezomib.
In its written advice the CHMP recommended that the proposed clinical program consist of a single 12-week, four-arm, factorial-designed trial in CIPN
that would seek to demonstrate AmiKet[TM]'s superiority compared with placebo and with each of the component drugs of AmiKet[TM], amitriptyline and ketamine.
During the fourth quarter of 2011, EpiCept received permission from the FDA to commence Phase III clinical development of AmiKet[TM] for the treatment of CIPN
and was encouraged to apply for Fast Track designation, which was granted in April 2012.
During the fourth quarter of 2011, EpiCept met with the FDA to review clinical, regulatory and CMC plans for AmiKet[TM] in CIPN
that would support an application for FDA marketing approval.
We believe that the engagement will result in a greater level of market appreciation for the consistently positive clinical results we have achieved in a variety of neuropathic pain indications including recent positive data in CIPN
, the significant market potential we have identified in an indication that is woefully underserved, and the recent favorable End-of-Phase II meeting with the FDA.
Every year, millions of cancer survivors suffer from the effects of their chemotherapy, and no treatment is yet approved to treat CIPN
During the third quarter of 2011, EpiCept submitted its request for a meeting with the FDA to review clinical, nonclinical, regulatory and CMC plans for AmiKet[TM] in CIPN
that would support FDA marketing approval.
A successful outcome of an end-of-Phase II meeting with the FDA will provide clarity with respect to clinical data required for approval of AmiKet[TM] in CIPN
and will help advance ongoing partnership discussions.
More than 460 cancer survivors suffering from painful CIPN
were enrolled in the six-week study.