PHARMA NEWS
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Fertility drug Clomiphene
Clomiphene is a non-steroidal fertility medicine. It causes the pituitary gland to release hormones needed to stimulate ovulation (the release of an egg from the ovary).
Clomiphene is used to cause ovulation in women with certain medical conditions (such as polycystic ovary syndrome) that prevent naturally occurring ovulation.
Important information
Do not use clomiphene if you are already pregnant.
You should not use clomiphene if you have: liver disease, abnormal vaginal bleeding, an uncontrolled adrenal gland or thyroid disorder, an ovarian cyst (unrelated to polycystic ovary syndrome), or if you are pregnant.
Before taking this medicine
You should not use clomiphene if you are allergic to it, or if you have:
abnormal vaginal bleeding;
an ovarian cyst that is not related to polycystic ovary syndrome;
past or present liver disease;
a tumour of your pituitary gland;
an untreated or uncontrolled problem with your thyroid or adrenal gland; or if you are pregnant.
To make sure clomiphene is safe for you, tell your doctor if you have: endometriosis or uterine fibroids.
Do not use clomiphene if you are already pregnant. Talk to your doctor if you have concerns about the possible effects of this medicine on a new pregnancy.
It is not known whether clomiphene passes into breast milk or if it could harm a nursing baby. This medication may slow breast milk production in some women. Tell your doctor if you are breast-feeding a baby.
Using clomiphene for longer than 3 treatment cycles may increase your risk of developing an ovarian tumor. Ask your doctor about your specific risk.
Fertility treatment may increase your chance of having multiple births (twins, triplets). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.
Clomiphene side effects:
Get emergency medical help if you have any of these signs of an allergic reaction to clomiphene: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some women using this medicine develop a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment. OHSS can be a life threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS:
stomach pain, bloating;
nausea, vomiting, diarrhea;
rapid weight gain, especially in your face and midsection;
little or no urinating; or
pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down).
Stop using clomiphene and call your doctor at once if you have:
pelvic pain or pressure, enlargement in your pelvic area;
vision problems;
seeing flashes of light or floaters in your vision;
increased sensitivity of your eyes to light; or
heavy vaginal bleeding.
Common clomiphene side effects may include:
hot flashes;
headache;
breast pain or tenderness;
mild stomach discomfort; or
breakthrough bleeding or spotting.n
FDA approves Viberzi (eluxadoline) for Irritable Bowel Syndrome with Diarrhoea (IBS-D) in adults
Recently, Actavis plc (NYSE: ACT) announced that Viberzi (eluxadoline) was approved by the Food and Drug Administration (FDA) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhoea (IBS-D). Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.
The FDAs approval of Viberzi is the first step to providing physicians with a new, evidence-based, treatment option for their adult patients with IBS-D, said David Nicholson, Executive Vice President, Actavis Global Brands RD. At Actavis, we are dedicated to providing new treatment options, and the development of new agents that help address the most bothersome symptoms of IBS-D. We are very pleased to be working with the FDA to advance this IBS-D treatment and we eagerly await DEA scheduling determination later this year.
IBS-D is a multifactorial disorder marked by recurrent abdominal pain or discomfort and altered bowel function that affects as many as 15 million adult Americans, impacting about twice as many women as men.
There are few treatment options available for IBS-D, particularly options that relieve both the diarrhea and abdominal pain associated with IBS-D.
The unpredictable symptoms experienced by patients with IBS-D can have a significant impact on everyday life, said William D. Chey, MD, Nostrant Professor of Gastroenterology at the University of Michigan Health System. Its exciting when physicians are able to add an additional treatment option like Viberzi to their toolbox for patients with IBS-D.
The FDA has recommended that Viberzi be classified as a controlled substance. This recommendation has been submitted to the U.S. Drug Enforcement Administration (DEA).
About Viberzi
Viberzi is an orally active compound indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in men and women. Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.
Efficacy was established in two Phase III clinical studies, demonstrating significant superiority over placebo on the composite endpoint of simultaneous improvement in both abdominal pain and diarrhea at both 75 mg and 100 mg twice daily doses. The primary efficacy responder endpoint was evaluated over the duration of double-blind, placebo-controlled treatment. Response rates were compared based on patients who met the daily composite response criteria (improvement in both abdominal pain and stool consistency on the same day) for at least 50% of the days from weeks 1 to 12 (FDA endpoint) and weeks 1 to 26 (European Medicines Agency
endpoint).
The most common adverse events in the two Phase III clinical trials were constipation (7% and 8% for eluxadoline 75 mg and 100 mg; 2% for placebo) and nausea (8% and 7% for eluxadoline 75 mg and 100 mg; 5% for placebo). Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg eluxadoline. Rates of discontinuation due to constipation were low for both eluxadoline and placebo (2%) and similar rates of constipation occurred between the active and placebo arms beyond 3 months of treatment. A total of 2,426 subjects were enrolled across the two studies.
About IBS-D
Irritable bowel syndrome with diarrhoea (IBS-D) is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 15 million patients in the U.S. Although the exact cause of IBS-D is not known, symptoms are thought to result from a disturbance in the way the gastrointestinal tract and nervous system interact. IBS-D can be debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-D is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.n
Source: drugs.com
