First anti-diarrheal drug for HIV/AIDS patients receives FDA approval
SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.
Fulyzaq is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria or parasite. Patients take Fulyzaq two times a day to manage watery diarrhea due to the secretion of electrolytes and water in the gastrointestinal tract. Derived from the red sap of the Croton lechleri plant, Fulyzaq is the second botanical prescription drug approved by FDA. A botanical drug product is often a complex mixture derived from one or more plant materials with varying degrees of purification.
The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy with a history of diarrhea lasting one month or longer. The median number of daily watery bowel movements was 2.5 per day. Results showed that 17.6% of patients taking Fulyzaq experienced clinical response, compared with 8% taking placebo. In some patients, a persistent anti-diarrheal effect was seen for 20 weeks.
Fulyzaq is distributed by Salix Pharmaceuticals, based in Raleigh, N.C. under license from Napo Pharmaceuticals Veregen is marketed by Florham Park, N.J.-based PharmaDerm.
FDA approves J&J drug-resistant tuberculosis treatment
WASHINGTON — The U.S. Food and Drug Administration has approved a new drug from Johnson & Johnson for patients with tuberculosis who do not respond to other treatments, the company announced.
Tuberculosis is an air-spread infection that usually attacks the lungs, but also affect the brain, the spine and the kidneys. The drug blocks an energy-producing enzyme the tuberculosis bacteria needs to survive and is the first drug in 40 years to attempt to cure the disease using this type of treatment.
Following a positive review by an advisory panel last month, the FDA on Monday approved the drug, chemically known as bedaquiline and to be marketed as Sirturo.
In 2011, nearly 9 million people around the world became sick with TB, according to the Centers for Disease Control and Prevention, and there were 1.4 million TB-related deaths. The disease requires six to nine months of drug treatment.
Pharmacists employ grassroots efforts to officially recognize pharmacists as healthcare providers
NEW YORK — A St. John’s University College of Pharmacy and Health Sciences Doctor of Pharmacy Candidate last week picked up on a petition to recognize pharmacists as healthcare providers and filed the petition on the Obama Administration’s "We the People" web site, according to a report published online by The Pharmacopedia.
The petition, filed by Steve Soman, is a replication of a similar charge started Dec. 11, 2011 on Change.org by pharmacist Sandra Leal. The movement even has its own Facebook page.
To date, the Change.org petition has garnered 21,951 signatures, 3,049 shy of a 25,000 signature goal. The "We the People" site has generated 1,052 signatures to date. That petition needs to reach 25,000 signatures by the end of January in order to qualify for an official White House response.
Both petitions are seeking to qualify pharmacists as healthcare professionals under the Social Security Act. "Despite overwhelming evidence of the positive impact pharmacists can have on patient health, pharmacists are not recognized as healthcare providers under the Social Security Act and therefore cannot be paid by Medicare for therapy management and patient consultation services," the petition reads. "The Social Security Act does recognize other healthcare professionals such as dieticians, nurse practitioners, physician assistants, nurse midwives and clinical social workers."
For the full Pharmacopedia report, click here.