A Phase 3 clinical trial of patients with travelers' diarrhea demonstrated that Aemcolo was superior to placebo (P=.0008) and non-inferior to ciprofloxacin.
There was no significant difference between the two therapies in odds ratios for efficacy, diarrhea, or diarrhea-related study withdrawals.
The FDA will be working with manufacturers to use blister packs or other single-dose packaging in efforts to limit the number of doses in a package.
Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
In Phase 3 clinical trials involving patients with travelers' diarrhea, Aemcolo was found to be superior to placebo (P=0.0008) and non-inferior to ciprofloxacin.
A total of 206 cases of Cyclospora infections have been reported to the CDC as of August 2, 2017 among individuals who became ill on or after May 1, 2017.
Data from the analysis showed a 73% mean reduction in diarrhea episodes from baseline after treatment with Mytesi for 24 weeks.
Ohio experienced a nearly 5-fold increase in cryptosporidiosis cases in 2016, with 1,940 reported cases compared with an average 399 cases during the prior 4 years.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ribaxamase (SYN-004; Synthetic Biologics) for the prevention of Clostridium difficile infection (CDI).
The analyses found no statistically significant difference between statin use and lower gastrointetinal conditions in constipation (OR 0.96, 95% CI: 0.87-1.05; P=0.33), abdominal pain (OR 0.95, 95% CI: 0.88-1.02; P=0.15), or colitis (OR 1.02, 95% CI: 0.91-1.14; P=0.73).
That FDA has approved Xermelo (telotristat ethyl) tablets as the first oral treatment for carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
Bezlotoxumab (Zinplava) is effective in reducing the risk of recurrent Clostridium difficile infection, according to research published in the New England Journal of Medicine.
Clinicians should consider performing a screening electrocardiogram for patients who present after acute or chronic high-dose ingestion.
Patients given bezlotoxumab exhibited significantly less Clostridium difficile infection (CDI) recurrence regardless of choice of standard of care (SoC) antibiotics, according to a study presented at IDWeek.
Crofelemer is a botanical drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest.
The FDA has granted MGB-BP-3 (MGB Biopharma) Qualified Infectious Disease Product (QIDP) designation for the treatment of Clostridium difficile-associated diarrhea (CDAD).
The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Movantik (naloxegol; AstraZeneca) tablets.
A slow but consistent increase in fidaxomicin use has been seen over time for the treatment of Clostridium difficile infection mostly in combination with other systemic antibiotics, study authors reported in Springer Plus.
Merck announced that the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10-5 recommending the approval of Zinplava (bezlotoxumab) for the prevention of Clostridium difficile (C. difficile) infection recurrence.
An increase in loperamide (Imodium) abuse as an opioid substitute has been seen among patients trying to self-treat their opioid addiction, according to a case studies report published in Annals of Emergency Medicine.
Appili Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for ATI-1501 (metronidazole) for the potential treatment of Clostridium difficile infection (CDI) in children.