As expected, Neos Therapeutics Inc. received a complete response letter (CRL) for Cotempla XR-ODT, its orally disintegrating tablet (ODT) version of methylphenidate, delaying its commercial foray into the attention deficit hyperactivity (ADHD) space, though the Dallas-based firm is hoping to offset that delay with an earlier-than-expected introduction of an ODT version of Adderall XR (d-amphetamine).

Neos has a Jan. 27 PDUFA date for its new drug application (NDA) for NT-0202, which, if approved would be the first amphetamine ODT product for ADHD, noted Vipin Garg, president and CEO, during the firm’s third quarter earnings call. Assuming an FDA nod, Neos plans to begin commercializing the drug in the second quarter of 2016, a quarter earlier than management had previously guided.

That means Neos still is guiding for sales and marketing expenses next year to fall within its previous range of $50 million to $60 million, though perhaps at the lower end, acknowledged Richard Eisenstadt, chief financial officer.

“We’re going to be using the same sales force for both products,” he said. The Cotempla delay will “save us some money and other peripherals, and other items dedicated to Cotempla will be put on hold,” but “we’ve actually done a lot of work that is usable for both products.”

That same sales team also would be responsible for selling the liquid formulation of Adderall XR, which is expected to be submitted to the FDA in the fourth quarter of this year, though Neos has indicated that drug, NT-0201, will be a modest seller vs. the ODT products, particularly with the introduction of a competing product from Tris Pharma Inc. Dynavel XR (amphetamine) gained approval last month as a once-daily, oral liquid treatment for ADHD.

“The liquid was basically an add-on to the ODT products,” which are driving the value of the company, said Garg.

Both the liquid and ODT products are designed to be easier-to-use formulations of Adderall XR, a staple in the stimulant category for children with ADHD. Neos’ technology uses small ion particles containing the drug, coated with a membrane polymer film and put into the orally disintegrating tablet – or liquid – so that when ingested, the micro particles distribute the drug on a controlled-release basis.

The technology has run into regulatory snags before. Like Cotempla, NT-0202 suffered an initial setback at the FDA, earning a CRL in September 2013. Neos resubmitted the application in July, with the inclusion of data from pharmacokinetic study confirming the product’s commercial-scale manufacturing process and stability.

The FDA request for in the Cotempla CRL is “similar,” Garg said, in that it seeks confirmatory data that the commercial-stage product is up to snuff. But rather than stability data, the agency is asking that Neos complete a bioequivalence bridging study to establish that the commercial-grade material to be used in the marketed product is the same as the clinical trial material used in the firm’s efficacy trials of Cotempla.

Despite having done “extensive in vivo work,” the FDA has “concerns that our commercial material may not be completely representative of what we used in clinical trials,” Garg told investors. “So that’s really the disconnect here.”

He pointed out that the agency did not raise any safety or clinical data issues. As reported at the American Academy of Child and Adolescent Psychiatry meeting in San Antonio, Texas, last month, a phase III trial showed that Cotempla resulted in statistically significant improvement in ADHD symptom control compared to placebo across the classroom day in children with ADHD, as defined by the SKAMP-Combined score scale.

Garg said Neos will meet with the FDA to fully understand the outstanding issues. As for the bridging study, he said he believes the firm could complete that trial by the second quarter of 2016, for potential resubmission of the NDA in the third quarter of next year. It likely would be a class II resubmission, allowing for a six-month review.

ADHD is a crowded – and multibillion-dollar – market. Stimulants such as Ritalin (methylphenidate) and Adderall both enjoyed blockbuster status, though they’ve now gone generic. And Neos will be competing with next-generation formulations of drugs from companies such as Highland Therapeutics Inc., which recently launched a second pivotal trial of HLD-200, a compound designed to have delayed and extended-release characteristics that allow it to be taken before bedtime.

Neos, which posted a net loss of $9.4 million, ended the third quarter with about $102.9 million in cash, equivalents and investments. Those included gross proceeds of $82.8 million raised in a July IPO, in which the firm sold 5.52 million shares priced at $15 each.

Its shares (NASDAQ:NEOS), which traded as high as $15.60 Wednesday, ended the day at $14.28, for a gain of $1.45, or 11.3 percent.