Defender Pharmaceuticals Receives Complete Response Letter from the U.S. Food and Drug Administration for its Intranasal Scopolamine (DPI-386) New Drug Application for the Prevention of Nausea and Vomiting Induced by Motion in Adults

Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced the issuing of a Complete Response Letter (CRL) , by the U.S. Food and Drug Administration (FDA) to the Company’s New Drug Application (NDA) for intranasal scopolamine (DPI-386) for the prevention of nausea and vomiting induced by motion in adults.

“Following our review of the CRL, we plan on scheduling a formal meeting with the FDA to fully understand the issues raised in the CRL so we can develop and implement a comprehensive action plan,” said Barry I. Feinberg, M.D., President & CEO of Defender Pharmaceuticals. “We remain confident that our intranasal scopolamine is a safe and effective therapy for the prevention of motion sickness, and we will work closely with the FDA to ensure that we can bring this innovative new product to the market.”

About intranasal scopolamine (DPI-386) Development Program

Defender has worked with the United States Naval Medical Research Unit (NAMRU-D) and the National Aeronautics and Space Administration (NASA) on its intranasal scopolamine development program that is focused on specific military personnel and astronauts.

To date, more than 1,300 patients have participated in Defender clinical studies, including over 500 participants in the DPI-386-MS-33 study. Given the successful outcome of DPI-386-MS-33, Defender has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for DPI-386 Nasal Gel for the prevention of nausea and vomiting induced by motion in adults.

Defender is also developing intranasal formulations designed to treat a wide variety of indications. We believe these new products have the potential to help safeguard health across civilian and military populations.

About Motion-Related Discomfort
Certain motions cause discomfort in individuals while engaged in various leisure or travel-related activities. Most forms of travel, whether on land, in the air, or on the water, can trigger symptoms such as nausea and vomiting (example: flying, boating/fishing, car, bus, and train). Symptoms induced by motion can also have a detrimental impact on the ability of various military personnel and astronauts to perform assigned duties, potentially impacting readiness and negatively impacting resources. Motion-related discomfort is a common and transient response to unfamiliar or unnatural motion or contradictory spatial sensory information, resulting in decrements to performance of tasks, pallor, cold sweating, nausea and vomiting. Prolonged exposure to certain motions may induce sopite-related symptoms such as loss of drive and concentration, drowsiness, sleepiness, apathy, depression, and a feeling of impending doom.

Ref : https://en.wikipedia.org/wiki/Scopolamine

Defender Pharmaceuticals Receives Complete Response Letter from the U.S. Food and Drug Administration for its Intranasal Scopolamine (DPI-386) New Drug Application for the Prevention of Nausea and Vomiting Induced by Motion in Adults

No evidence found linking anti-nausea drug to birth defects

No evidence found linking anti-nausea drug to birth defects: No evidence has been found to link the anti-nausea drug Zofran to an increased risk of birth defects. In fact, women with the condition who took Zofran reported fewer miscarriages and pregnancy terminations and higher live birth rates than women with extreme morning sickness who did not take the drug.

Popular Morning Sickness Drug Safe in Pregnancy, Study Finds

Metoclopramide (INN)   is an antiemetic and gastroprokinetic agent. It belongs to a group of medicines called ´dopaminergic´ blockers. It is commonly used to treat nausea and vomiting, to facilitate gastric emptying in people with gastroparesis, and as a treatment for the gastric stasis often associated with migraine headaches.

Ref : http://jama.jamanetwork.com/article.aspx?articleid=1752754

Popular Morning Sickness Drug Safe in Pregnancy, Study Finds - Drugs.com MedNews

Severe morning sickness patients get relief from anti-seizure drug

 In continuation of my update on gabapentin

"The study showed that after two weeks of gabapentin therapy, the seven women experienced an average 80 percent reduction in their nausea and a 94 percent reduction in their vomiting and near normal levels of eating and drinking," Guttuso says. After this study was published, Guttuso knows of five more women with hyperemesis gravidarum that tried gabapentin and all experienced excellent relief.

The women needed to take gabapentin on average until about half way through their pregnancies before they could stop it without recurrent nausea and vomiting.

One of the potential concerns with gabapentin was that two of the babies born to patients in the UB study were found to have congenital defects. As a result, the Food and Drug Administration placed the study on clinical hold in April 2011 until further safety data was available on the use of gabapentin during pregnancy.

By May 2012 several pregnancy registries and other studies had reported that the rate of congenital defects among a total of 258 infants born to women taking gabapentin early in their pregnancies was about the same as the rate of congenital defects in the general population. After reviewing these findings, the FDA removed the clinical hold allowing Guttuso to resume his research on the effects of gabapentin on hyperemesis gravidarum. Although the results of the small pilot study were very encouraging, Guttuso emphasizes that a placebo-controlled study among many more patients needs to be conducted in order to know if gabapentin truly is effective for hyperemesis gravidarum. "The evidence right now is still very preliminary," he states.

Severe morning sickness patients get relief from anti-seizure drug