Anyone who’s ever endured a migraine knows all too well the experience of waiting for the meds to kick in and hoping the nausea isn’t so bad they are vomited up before that happens.
BioDelivery Sciences thinks its new drug Elyxyb (celecoxib oral solution), a fast-acting liquid, may just be the answer to those fervent prayers. It’s the first and only FDA-approved ready-to-use oral solution for adults in the acute treatment of migraine, with or without aura. The company plans to launch it early next month.
“The reason why this is so much more beneficial is because that liquid formulation when it hits your duodenum, it helps with absorption,” Sai Rangarao, BDSI’s vice president and head of marketing and commercial operations, said. “It leads to much better tolerability by your GI tract that takes it in via the small intestine, versus a capsule that has to go dissolve and then—this is not really in scientific terminology—but get working.”
BDSI acquired Elyxyb from Dr. Reddy’s Laboratories Limited, and it’s the biopharma’s first foray into the neurology space. The drug is a natural complement to BDSI’s pain franchise, and Rangarao said there is the possibility of more “bolt-ons” in neurology.
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With so much interest in migraines these days, why would Dr. Reddy’s want to sell it off after approval? Rangarao says since the beginning of the program, there were board changes, leadership changes and a change in the company’s vision, leading it to look for a partner to sell the product.
So, while it may not be practical for a large company with a lot different areas, for a smaller firm looking to focus on two areas—one of them being neurology—it just made sense.
And sure, the migraine field may seem overcrowded and laden with celebrity endorsements—Serena Williams for AbbVie’s Ubrelvy, Khloe Kardashian, Whoopi Goldberg and Tori Spelling for Biohaven’s Nurtec—Rangarao sees this as a positive for the launch.
“We’re basically able to ride that wave of awareness into providing the solution. So we’re not too worried about doing broad blast awareness campaigns on migraine. We’re really focused on branded messaging, very targeted, appropriate messaging,” he said.
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There are no plans for celebs, but rather a focus on digital, print leave-behinds, work with advocacy groups andm because BDSI is so confident in the product, a strong sampling program.
Elyxyb, which will be prescribed in six-packs of small, portable bottles, features a weirdly wonderful flavor profile reminiscent of Alice in Wonderland’s “Drink me” bottle—a mix of, banana, peppermint and bubblegum. BDSI isn’t just trying to appeal to kids (although that is the hope in the future); that mix of flavors is very deliberate in addressing the nausea that often accompanies a migraine.
