Pharmaceutical companies are not just looking for new anti-HIV medications with fewer toxicities these days'they are also developing drugs specifically designed to combat the adverse side effects linked with currently available antiretrovirals. At East Brunswick, N.J.'based Savient Pharmaceuticals, researchers are organizing a Phase II clinical trial of a medication to treat pain caused by HIV-related neuropathy. Called Prosaptide, the drug is a peptide derived from the human growth protein prosaposin. Since it is a natural compound, it is believed to be free of the side effects caused by other types of pain medications.
Peripheral neuropathy'usually marked by pain, tingling, or loss of feeling in the hands and feet'is relatively common among HIV-positive people and may be related to HIV disease or its treatment. Some AIDS experts worry that the longer patients take anti-HIV drugs, the greater their chances are for experiencing worsening neuropathy symptoms. Commonly used medications to treat neuropathy include opioids, anticonvulsants, and antidepressants, which can cause such adverse side effects as dizziness, drowsiness, cardiac arrhythmia, and even addiction.
'Current therapies for HIV/AIDS-related neuropathic pain include topical or oral analgesics, which have limited efficacy, or central nervous system'acting drugs, which are often accompanied by unacceptable side effects,' says Savient chairman and CEO Sim Fass. 'Our objective is to develop an analgesic product that effectively mitigates peripheral neuropathic pain without the dose-limiting side effects typical of current therapies in use.'
The company began recruiting patients for the clinical trial at the end of the August and hopes to begin the efficacy test later this year.
