Foam delivery to make earaches less of a headache for parents

For many parents, earaches are among the most fearsome of the common childhood maladies. Especially in younger children, earaches are almost invariably accompanied by cries of pain, as children suffer with an almost intolerable level of pressure, feeling relief only when they sleep – or when their medication kicks in.

Often that medication needs to be administered several times a day, with the application itself a major challenge – especially with little kids who balk at the idea of a cold, oozing liquid splattering in their ear canals, and are too young to realize that it’s for their own good.

While Israeli bio-tech start-up Otic Pharma doesn’t have a miracle cure for earaches, it does have a way to make getting medicine into the ear easier – and make the deployment more effective. Using foam instead of drops to deliver medicine, the company’s product FoamOtic Externa “provides good coverage of the infected ear canal, and the continued release of the drug allows once-daily dosing and better compliance, which is a major advantage for kids,” according to Otic Pharma’s Dr. Orna Palgi. This enables the children to get relief more efficiently, and saves parents the need to go through repeat “operations” as they try to relieve their children’s ear pain.

In a just completed test, Otic found that “once-daily dosing of FoamOtic Externa (ciprofloxacin 0.3% otic foam) demonstrated excellent safety and a similar clinical cure rate to twice-daily dosing of Ciprodex ear drops (0.3% ciprofloxacin and 0.1% dexamethasone otic suspension, Alcon), the world leading marketed ear drops for Acute Otitis Externa (AOE),” the medical term for “swimmer’s ear,” aka the common earache. The Phase 2 clinical trial, conducted in Israel, included 220 minor and adult patients, age six months and older.

FoamOtic Externa is a proprietary, foam-based extended-release formulation of an antibiotic called ciprofloxacin, commonly used to kill the bacteria that cause ear infections, although it is also used to treat respiratory, urinary tract, gastrointestinal, and abdominal infections. For those maladies, ciprofloxacin is administered in the form of immediate or extended-release tablets, as an oral suspension, or as a solution for intravenous infusion.

The only form that works for ear infections, though, is drop form – and drops don’t always work so well, according to Palgi. Besides having a high “resistance level” – as in, it’s very difficult to get kids into the right position and keep them there long enough to aim the dropper into the ear canal effectively – drops that flow into the ear can flow right back out, even if the patient is trying to be cooperative.

Foam foils those forms’ failings, said Palgi. Instead of requiring a young patient to lay their head horizontally, the foam form of ciprofloxacin can be administered in a normal, upright position. It comes in a small, easy to insert capsule, which slowly expands and dissipates in the ear – delivering the antibiotic itself in a timed manner, continuously releasing the antibiotic’s active ingredient to ensure full coverage and enabling the patient’s system to more effectively battle the bacteria.

But for most parents, the best part of FoamOtic Externa is likely to be that it needs to be used once a day, instead of the three or four times a day that drops need to be inserted. And, according to Dr. Shmuel Gur, a pediatrician with Israel’s Clalit Health Services, where Otic has been running tests, the once-a-day feature is one of the biggest selling points for parents, and for patients themselves. “FoamOtic Externa is an effective product, easy to use, and was very well accepted by the patients,” he said. “It enhances patients’ compliance since it is conveniently applied once a day. I will definitely recommend using is product based on patients’ feedback.”

Buoyed by the successful Phase 2 trial, the company is moving on to a Phase 3 trial in the US, seeking FDA approval. “We are very pleased with these positive results with once-daily dosing of FoamOtic Externa,” said Palgi. “Based on these data, we will be initiating a US-based Phase 3 trial with FoamOtic Externa during 2015.”