A drug designed to prevent people living with the HIV virus from experiencing a common and potentially deadly side effect of HIV medications has hit a roadblock. It’s mired in litigation that could delay availability of the drug for months, according to information released last month by the Food and Drug Administration in Washington.
The drug, Fulyzaq (crofelemer), is designed to treat excessive cases of diarrhea—a common condition in HIV-positive people. The drug was developed by Napo Pharmaceuticals, a San Francisco-based biotechnology firm, in partnership with North Carolina-based Salix Pharmaceuticals in 2008. After a series of clinical trials and reviews, the drug was submitted to the FDA for approval in 2011. The agency approved the drug for distribution in late 2012. However, disagreements, bickering and red tape between the two drug makers has delayed the widespread availability of the drug to patients and a lawsuit was filed by Napo Pharmaceuticals against its partner, Salix Pharmaceuticals. Among other things, Napo accused Salix of delaying the release of Fulyzaq.
In a press release from May, officials from Salix said the company was “working with the FDA to finalize release specifications.” The company added that it would “expedite the commercial launch of Fulyzaq.” Additionally, in a media release in June, the head of communications for Salix Pharmaceuticals advised that the drug was “stocked and available to patients with a prescription through Walgreens Specialty Pharmacies.” However, an attorney for Napo Pharmaceuticals contends that a number of physicians have advised the company that countless patients have complained about being unable able to get prescriptions for Fulyzaq filled at any pharmacy, including Walgreens.
At any rate, while the legal wrangling between the two drug makers continues to delay the release of the drug, patients suffering from excessive gastrointestinal ailments related to HIV medications will continue.
For example, Earl, a 54-year-old African-American man living and working in Washington, D.C., has been living with the HIV virus since the late 1980s. With a virtually undetectable viral load and a healthy, active and solid medication regiment, Earl said he still periodically must endure severe intestinal and bowel issues—a direct result of his HIV meds.
“I think any delay of treatment that will help alleviate some of the many side effects HIV-positive people have due to their meds is a disservice to the patients it is designed to help,” said Earl.
To find out more about Fulyzaq and its success in clinical drug trials, visit www.herbalgram.org.