Evoke Pharma ($EVOK) showed in a recent study that its nasal spray for the delivery of a generic gastrointestinal drug performed better than the traditional oral form. The nasal delivery method could help patients with diabetic gastroparesis take the drug when they are suffering from nausea and have difficulty swallowing a pill.
As published on Dec. 25, 2013, in the journal Neurogastroenterology & Motility, the Phase IIb study demonstrated that 89 patients in the multicenter study displayed fewer symptoms when dosed four times a day for 6 weeks with EVK-001, Evoke's metoclopramide nasal spray, as compared with the oral generic. EVK-001 delivers metoclopramide to the mucosa of the nasal cavity, which is highly vascularized and allows the drug to be directly transferred to the bloodstream.
Metoclopramide is one of the only drugs known to mitigate the symptoms of gastroparesis but is often taken orally--which spells trouble when you're dealing with a stomach disease.
"In gastroparesis, movements of the stomach are slowed or stopped, not moving food or drug into the small intestine," Evoke CEO Dave Gonyer told FierceDrugDelivery. "Drugs aren't necessarily getting where they need to get, and are neither reliable nor predictable. Bypassing the stomach and going directly into the bloodstream is a novel approach."
Gonyer noted that there haven't been any new FDA-approved drugs for the management of gastroparesis symptoms since 1980 and consequently very few on the market.
But gastroparesis, as a corollary to diabetes, is on the rise. And that could give Evoke a piece of the huge diabetes market. One analyst, as quoted by Reuters, estimated that the nasal spray could bring Evoke more than $400 million in peak annual sales.
"Diabetes is the number one known cause of gastroparesis, and the diabetes market is 25 million [patients] or more and growing," Gonyer said. "We know there are approximately 10 to 16 million with signs and symptoms of the disease and currently, from a prescription basis, about 4 million treated. We'd like to start capturing some of that low-hanging fruit."
Johnson & Johnson's ($JNJ) Janssen once made the oral gastroparesis drug Propulsid, but it was pulled from the market after 20 years due to its side effects, leaving metoclopramide the only generic in the field.
Gonyer said Evoke is gearing up for a Phase III trial and should have data by 2015. In December, the company recruited CRO SynteractHCR for the late-stage effort.
- get the journal abstract
- here's the release
- and here's Reuters' take
Editor's note: This article was updated to correct a statement regarding the existence of other approved drugs used to treat symptoms of gastroparesis. Erithromycin, for example, is also available.