SCOLR Ready To Answer FDA Questions On 12-Hour Pseudoephedrine ANDA

FDA has raised questions on "minor" issues regarding SCOLR Pharma's proposed nonprescription 12-hour pseudoephedrine tablet, according to the firm.

SCOLR said Jan. 20 the "complete response letter" it received from FDA does not question the product's safety or efficacy.

The company declined to identify the agency's questions, but said it "believes it can provide the information to the FDA expeditiously."

Bothell, Wash.-based SCOLR said it filed an abbreviated new drug application in August 2008 for a 120 mg PSE tablet that employs the company's patented controlled delivery technology.

In a release, Tanya Raco, associate VP of regulatory affairs and quality assurance, says SCOLR "will continue to work closely with FDA to address the questions raised" and move toward approval.

FDA uses complete response letters to identify an application's deficiencies and to recommend actions a sponsor can take to address them.

SCOLR says it remains in talks with potential partners regarding the 12-hour PSE product and is open to talking with other firms interested in an alliance.

The firm's Web site says the CDT platform optimizes "bioavailability of active ingredients while diminishing adverse side effects, improving dosing compliance and maximizing overall product effectiveness." The technology is currently used only in dietary supplement products.

In a November 2008 presentation to analysts, a SCOLR executive said he expected FDA's review of the ANDA to last 18 to 24 months.

The company declined to say whether FDA's letter changes its expected timeline for making the PSE product available.

The ANDA was the company's first formal submission to FDA. While products containing PSE already are available nonprescription, an ANDA was needed for SCOLR's proposal to market a drug with its delivery technology.

Like other PSE-containing nonprescription drugs, SCOLR's proposed product would have to be sold from behind store counters.

The road to the OTC market for SCOLR's CDT platform has not been smooth. Plans for a 12-hour CDT-based phenylephrine formulation were scrapped in February 2007 after a trial failed to justify continued development (¹ 'The Tan Sheet' Feb. 19, 2007, In Brief).

Wyeth then terminated an alliance with the firm in March 2007 after deciding not to proceed with plans for an extended-release ibuprofen product using CDT (² (Also see "SCOLR Expects New Licensing Agreement This Year" - Pink Sheet, 14 May, 2007.), p. 18).

The departure of Wyeth caught SCOLR off-guard, a spokesperson admitted at the time (³ (Also see "SCOLR May File NDA For Ibuprofen Product Following Break With Wyeth" - Pink Sheet, 19 Mar, 2007.), p. 13).

SCOLR has since moved ahead in developing CDT ibuprofen on its own, announcing in November 2008 that it had achieved "stellar" safety and efficacy results from a phase III clinical trial.

Still, the loss of development fees and licensing revenues from Wyeth sliced the firm's total revenues during the first three quarters of its fiscal 2008 by 55 percent to $781,435.

SCOLR has had better results in the supplement market. The company's 14 percent increase in total revenues in its 2008 third quarter - July through September - was due primarily to royalty income gained through a partnership with Perrigo, which manufactures supplements using the CDT platform.

The company has plenty riding on the success of PSE- and ibuprofen-containing CDT products, which it says are its leading product candidates (⁴ 'The Tan Sheet' May 12, 2008, In Brief).

In December 2008, Daniel O. Wilds resigned as SCOLR's CEO and as a member of its board. A spokesman said in an e-mail that the "existing executive management team" is leading the firm on an interim basis.

The executives include Alan M. Mitchel, senior VP for business and legal affairs; Stephen J. Turner, VP and chief technical officer; and Richard M. Levy, chief financial officer and VP of finance.

- Dan Schiff ([email protected])