Diclegis, which contains the same ingredients as Bendectin, has a Pregnancy Category A status from the FDA, meaning that the results of controlled studies have not shown an increased risk to an unborn baby during pregnancy. The drug is for women who do not respond to conservative management of NVP.
“This is truly a milestone moment, not only for us at Duchesnay as this is our first product on the U.S. market, but also for the millions of pregnant women in America who have suffered from NVP symptoms without an FDA approved option for decades,” says Gilbert Godin, CEO, Duchesnay USA. “Healthcare professionals will now be able to provide patients with a prescription treatment specifically indicated to control NVP symptoms should pharmacological intervention be deemed appropriate. Diclegis has the potential to provide NVP symptom relief to millions of women in the U.S. each year. We expect Diclegis to be widely available in late May.” A full product website, diclegis.com, will also launch in May, and Godin encourages patients, healthcare providers, and caregivers to visit the site. In addition, more information will become available on duchesnayusa.com. The company also plans to launch a free mobile app this summer for patients that will provide dosing reminders, tips, and resources for managing NVP.
NVP can affect 70 to 85 percent of pregnant women with symptoms ranging from nausea to severe vomiting and retching that can last throughout the day. Some pregnant women may experience symptoms throughout their pregnancy. “While the exact causes of morning sickness still remain unknown, we are starting to understand more about this medical condition,” says Shannon M. Clark, M.D., MMS, co-Investigator in the Diclegis clinical trial and associate professor in maternal-fetal medicine at University of Texas Medical Branch, Galveston. “It is a common misnomer that the symptoms NVP only occur in the morning. In fact, studies have found that approximately 80 percent of patients experience symptoms throughout the entire day. Many women have seen morning sickness as a rite of passage and that it is the sign of a healthy pregnancy that all women must endure.”
Dr. Clark cautions against dismissing NVP as simply a normal part of pregnancy.” If symptoms of NVP go unchecked, they may grow in intensity and become more difficult to manage. The point that I would like to make clear is that NVP is a real medical condition,” she said. Dr. Clark clarifies that NVP isn’t a life-threatening medical condition. “However, if it is left untreated, it can progress to a more potentially dangerous or serious condition, which we all know as hyperemesis gravidarum,” she told Med Ad News. “In fact, data suggests that failure to treat the early stages of NVP increases the risk of later hospitalization for hyperemesis gravidarum. Hyperemesis gravidarum is a severe form of NVP that can cause fluid abnormalities, electrolyte abnormalities, and a change in acid base in the patient as well as nutritional deficiencies and weight loss. For this reason, pregnant women should tell their healthcare professionals about any regular episodes of nausea and/or vomiting so that their need for treatment can be assessed.”
The two active ingredients in Diclegis that reduce nausea and vomiting, doxylamine succinatem which is an antihistamine and pyridoxine hydrochloride, or vitamin B6, have been recommended as a first-line pharmacotherapy by the American Congress of Obstetricians and Gynecologists (ACOG) guidelines for the last nine years, according to Dr. Clark. “Many pregnant women and even their friends and family don’t realize that treatment may be necessary,” she said. “They simply see morning sickness as just an unpleasant part of pregnancy. The lack of an FDA approved safe treatment option has been frustrating for the healthcare provider and the pregnant woman.”
When a patient begins her Diclegis treatment, she will take two tablets at bedtime, Dr. Clark says. “If this dose adequately controls symptoms the next day, the patient can continue taking two tablets at bed time. If symptoms persist into the afternoon of day two, the patient will take her usual dose at bedtime in addition to a third tablet starting on day three. This would be one tablet in the morning and two tablets at bedtime.” The maximum dose is four tablets, with one in the morning, one tablet midday, and then two at bedtime. Also, Diclegis is to be taken as a daily prescription, and not on an as needed basis.
But for how long should a patient take Diclegis? After the failure of conservative measures such as lifestyle and dietary changes, the patient and her healthcare provider should discuss whether or not she is in interested in the product. “Historically, the symptoms of NVP last between six and eight weeks at which time the patient should take it even if she is feeling better so that she can have treatment during this crucial time,” Dr. Clark told Med Ad News. “As she gets further throughout her pregnancy, another conversation that she should have between her and her provider is to start tapering off the medication and see how her symptoms do.”
Regarding the cost of Diclegis to patients, the company is implementing “the triple AAA policy”, according to Godin. “The triple AAA is stands for affordability, accessibility, and availability,” he told Med Ad News. “On the point of affordability, Duchesnay USA is taking all possible means so that on average, the patient copay can be as low as $1 a day for a full course of treatment.” As for accessibility, the company is engaging with public and private payers to make a broad Diclegis coverage and believes that there are four reasons to be optimistic.
“I think that there is a fundamental right to treatment,” Godin told Med Ad News. “American women have the right to treat conditions that are important to them. Secondly, safety for the baby is of highest concern. After all, it’s a Pregnancy Category A and that should be of the utmost importance. Thirdly, the burden of disease may be considerable for the patients and for their employers. The fourth we believe that less liability for all stems from the first-line use FDA approved product with Pregnancy Category A treatment.”
The final component of Duchesnay USA’s triple AAA policy is the ability that the company has to bring relevant clinical information from a broad base of healthcare professionals and the responsibly to the public as the company continues to demonstrate safety and efficacy of the product, according to Godin.
“And I want to remind everyone also that we will continue to defend it against any kind allegation that we could face similar to those 30 years ago so that we can ensure continued availability of the treatment,” he told Med Ad News. “That is a very important point for us. I will only point out before I conclude that the unfortunate reason that Bendectin was voluntarily withdrawn from the time was because of the cost of the legal insurance was exceeding the revenues of the company, and therefore was not a viable marketing solution. We’re taking the means that this product is here for the long run and that we will be here to stand by any patients.”
REFERENCE: By Mia Burns; PharmaLive (April 2013)