Trulance (plecanatide ) - Constipação Idiopática Crônica

Novo tratamento para conztipação idiopática crônica (CIC).


January 19, 2017 -- The U.S. Food and Drug Administration today approved Trulance (plecanatide) for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients.

EPIDEMIOLOGIC DATA:

According to the National Institutes of Health, an estimated 42 million people are affected by constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.

DOSING:

Trulance, taken orally once daily, works locally in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function.

SAFETY AND EFFICACY:

The safety and efficacy of Trulance were established in two 12-week, placebo-controlled trials including 1,775 adult participants. Participants were randomly assigned to receive a placebo or Trulance, once daily. Participants in the trials were required to have been diagnosed with constipation at least six months prior to the study onset and to have less than three defecations per week in the previous three months, as well as other symptoms associated with constipation. Participants receiving Trulance were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo, and also had improvements in stool frequency and consistency and straining.

PRECAUTIONS:

Trulance should not be used in children less than six years of age due to the risk of serious dehydration. Trulance should be avoided in patients six years of age to 18 years of age. The safety and effectiveness of Trulance have not been established in patients less than 18 years of age. Trulance should not be used in patients with known or suspected mechanical gastrointestinal obstruction.

ADVERSE EFFECTS:

The most common and serious side effects of Trulance was diarrhea. Patients may experience severe diarrhea. If severe diarrhea occurs, patients should stop taking Trulance and contact their health care provider.

PRICE

Trulance is currently not available at retail pharmacies because it is recently approved by FDA and is under manufacturing process. 

Trulance is manufactured by New York, New York-based Synergy Pharmaceuticals Inc.

Source: FDA

Five Years of Cancer Drug Approvals Innovation, Efficacy, and Costs

http://jamanetwork.com/journals/jamaoncology/fullarticle/2212206

Cancer drug prices are rising faster than the prices in other sectors of health care, drawing concern from patients, physicians, and policy researchers. The annual cost of a new cancer medication now routinely exceeds $100 000, and medical bills have become the single largest cause of personal bankruptcy.


Mailankody &  Prasad (2015) identified drugs in oncology approved by FDA  from January 1, 2009, to December 31, 2013. During this time, 9 drugs received more than 1 approved indication. Of these 51 drugs, 21 (41%) exert their effect via a novel mechanism of action, while 30 (59%) are next-in-class drugs. Among 63 unique indications for approval, 22 drugs (35%) were approved based on RRs, 22 (35%) based on PFS, and 19 (30%) based on OS. 

The authors found little difference in the median wholesale price of 21 novel drugs and 30 next-in-class drugs approved over a 5-year period (next-in-class drugs, $119 765; novel drugs, $116 100; P = .42). Their results suggest that the price of cancer drugs is independent of novelty. 


Corresponding Author: Vinay Prasad, MD, MPH, Medical Oncology Service, National Cancer Institute, National Institutes of Health, 10 Center Dr 10/12N226, Bethesda, MD 20892 (vinayak.prasad@nih.gov).