AccuDial Pharmaceutical awaits FDA's green light to launch its OTC products with packaging and labeling innovations to allow for more accurate medication dosing.

CEO Bob Terwilliger says he hopes the innovations used with Children's AccuDial products become the norm for liquid pediatric OTCs.

However, a medication safety expert says the jury remains out on whether weight-based dosing is any safer in practice than age-based measurements.

AccuDial markets eight products with a label that rotates to show the correct dosage when a child's weight is selected. The Palm Beach Gardens, Fla., firm packages the products with a calibrated dosing spoon marked in milliliter and half-milliliter increments.

The drugs currently are available in Canada, and a U.S. launch is slated for late 2010 or first quarter 2011. AccuDial plans a two-pronged branded/ private label strategy for its U.S. roll-out.

Terwilliger said in an interview the firm has deals with several major drugstore chains to supply the Children's AccuDial branded product line. Separately, one chain will make AccuDial its exclusive store brand supplier of pediatric liquids, representing about 23 stock-keeping units.

The executive said the AccuDial products in Canada on average are priced midway between leading national brands and store brands. Terwilliger added AccuDial provides a slightly higher profit margin to the retailer than do name brands.

Labeling The Future

As FDA and industry trend toward requiring more foolproof dosing instructions and devices for OTCs, AccuDial may be placed strategically to grow through its own sales and through out-licensing.

Terwilliger said AccuDial seeks to license its bottle and label technologies, comprising 15 patents, to other brands. The firm already has nondisclosure agreements with two national brand manufacturers, he added.

"That is a very large part of our strategy," the CEO said. "We really believe that, four or five years from now, every product on the pediatric shelf for liquid products will be using our bottles and our labels."

AccuDial drugs entered the Canadian market in January and are sold in about two-thirds of pharmacies there. Terwilliger declined to comment on product sales but said the company expects to soon claim about 10 percent of Canada's overall analgesic, allergy and cough/cold market.

In less than a year, "we've gone from no position in the Canadian market to being in 4,000 stores," he said.

"And we're just now getting into the cough and cold season, so we're very optimistic that there's going to be a strong reaction to our product."

Virtue And Device

While Terwilliger said FDA accepts weight-based dosing for acetaminophen and ibuprofen, other ingredients - such as the diphenhydramine in the Nite Time Cough & Cold product - are typically dosed based on a child's age.

"All of our discussion and work that we've done with the FDA is to give them comfort that we are dosing and we do dose inside the monograph," he said, adding he hopes by year's end to receive a compliance letter from the agency, to be followed by the line's U.S. launch.

Terwilliger said he believes AccuDial is ahead of the curve on the dosing device and labeling issues that have elicited some disagreements between FDA and OTC manufacturers (¹ Also see "OTC Dosing Device Guidance Elicits Concern On Spoon Confusion, Added Cost" - Pink Sheet, 1 February, 2010.).

AccuDial products meet the specifications set by FDA's draft guidance on dosage delivery devices for liquid OTCs, he said. The November 2009 document advises firms to provide product-specific devices, standardize measurement units and simplify markings on the devices (² Also see "FDA Gets Strict On Liquid OTC Dosing Devices In Draft Guidance" - Pink Sheet, 9 November, 2009.).

AccuDial also touts that its products "comply with, and even exceed," recommendations promulgated by the Consumer Healthcare Products Association in late 2009 (³ Also see "CHPA Adopts Dosing Guidelines For OTC Pediatric Liquids" - Pink Sheet, 7 December, 2009.). AccuDial joined CHPA's Pediatric Cough/Cold Ingredient Efficacy Research Task Group in August 2010.

The dosing spoon that accompanies AccuDial OTCs will be replaced in some SKUs with a plastic syringe that plugs into the neck of the bottle to draw out the liquid. Terwilliger said the viscosity of some suspensions makes it difficult to measure them with the spoon device.

Innovations Seeking Practicality

Centers for Disease Control and Prevention official Dan Budnitz is encouraged by AccuDial's innovations in support of safer dosing practices.

Budnitz acknowledged weight-based dosing is pharmacologically preferable, but he said industry and academia have not reached a conclusion on its practicality for OTC drugs.

Budnitz leads the CDC-sponsored public-private partnership PROTECT - the Preventing Overdoses and Treatment Errors in Children Task Force - which recently addressed weight-based dosing at the behest of FDA.

"While people generally know children's ages, often parents - sometimes the dad - have no idea what the kid weighs," said Budnitz, who also directs the Medication Safety Program in CDC's Division of Healthcare Quality and Promotion.

"The answer that we came up with is, we don't know the best answer at this point, and just that it had to be studied in practice," he added.

PROTECT plans to meet in November to discuss issues related to medication safety, including packaging mechanisms to prevent children from accessing drugs and an "Up and Away" educational campaign, in development with CHPA, to remind caregivers to keep drugs out of the reach of young children.

Weight-Based Awareness

Ultimately, marketing AccuDial involves educating parents and caregivers about the benefits of weight-based dosing, which Terwilliger said is more sensible and less likely than age-based dosing to lead to over- or under-dosing children.

Pharmacists and doctors already know to dose by weight, so spreading the word to consumers is "not a difficult educational task, it's more of an awareness task," he said.

- Dan Schiff ( ⁴ d.schiff@elsevier.com )

AccuDial Expects Measure Of Success In Weight-Based OTC Dosing

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