WASHINGTON - Sepracor Inc. and its Japanese parent company Dainippon Sumitomo Pharma Co. Ltd. were mum about the details of a complete response letter they received from the FDA for their antiepileptic drug Stedesa (eslicarbazepine acetate), only stating that regulators would not approve the compound at this time.
Marlborough, Mass.-based Sepracor, which was acquired for about $2.6 billion last year by Dainippon Sumitomo, said it planned to meet with the FDA to discuss the agency's letter. (See BioWorld Today, Sept. 4, 2009.)
The companies had initially expected to hear from the FDA in January on Stedesa's new drug application. But regulators informed the firms that the agency needed more time to review new information Sepracor had submitted in November, which the drugmaker said was at the regulators' request. Sepracor has not disclosed the types or contents of that additional information for Stedesa's application, which was submitted in March 2009.
The company is seeking approval of the drug, a voltage-gated sodium channel blocker, as a adjunctive therapy to treat partial-onset seizures in adults with epilepsy.
Sepracor in December 2007 acquired the U.S. and Canadian development and commercialization rights to Stedesa from Portuguese drugmaker Bial-Portela & Ca SA.
The drug was studied in three multicenter, randomized, placebo-controlled Phase III trials involving more than 1,000 patients from 23 countries.
Study participants, who had a history of at least four partial-onset seizures per month after being treated with up to three concomitant antiepileptic drugs, were randomized to Stedesa or placebo. After a two-week titration period, patients were assessed over a 12-week maintenance period with continued follow-up over a one-year, open-label period.
Sepracor currently markets the sleep aid Lunesta (eszopiclone). The firm's other approved products include its bronchospasm drug Xopenex (levalbuterol), its chronic obstructive pulmonary disease medication Brovana (arformoterol tartrate) and its nasal allergy spray Omnaris (ciclesonide).
FDA: Acthar Data Difficult to Interpret
Drug reviewers Monday said Questcor Pharmaceuticals Inc.'s data for its investigational infantile spasms treatment Acthar (repository corticotropin injection) were difficult to interpret.
The drug, which has been used off-label for more than 50 years as a therapy for infantile spasms - a specific type of seizure seen in an epilepsy syndrome of infancy and childhood, known as West syndrome - will be discussed Thursday at a meeting of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee.
Only H. Lundbeck AS' Sabril (vigabatrin) is approved in the U.S. for infantile spasms, although prednisone also is used off-label to treat the condition.
In briefing documents posted Tuesday on the FDA's website, Questcor argued that while Sabril is an effective treatment, it is "not the best treatment option" for every patients with infantile spasms.
The firm noted that data from one study showed that Sabril demonstrated a 15.9 percent response rate defined as the elimination of spasms and resolution of hypsarrhythmia. In a second study, only the effect of treatment on spasm reduction was assessed, with results showing a 78 percent reduction in spasms with Sabril.
"Child neurologists believe that complete elimination of spasms and resolution of hypsarrhythmia are needed to give the best chance of IS not recurring," Questcor said. The firm also asserted that cessation of spasms alone "should not be the goal of treatment."
The company also pointed out Sabril's increased risk of vision loss. (See BioWorld Today, Jan. 6, 2009, Jan. 8, 2009, and Aug. 24, 2009.)
Sabril's approval, Questcor asserted, has had little impact on the demand for Acthar, a purified preparation of the naturally occurring corticotropin polypeptide. Acthar has been owned by several drugmakers, including Aventis, which later became Paris-based Sanofi-Aventis Group AS, from which Questcor acquired the rights in 2001.
Questcor first submitted a supplemental new drug application to the FDA in 2006, but received a complete response letter in May 2007. The agency, however, encouraged Questcor to try again by submitting published source data.
While Questcor showed due diligence in obtaining the most complete data available by submitting three studies in support of Acthar's efficacy and four evaluating its safety, regulators said Tuesday that those data need to be carefully considered.
Shares of Questcor (NASDAQ:QCOR) closed at $9.24 Tuesday, a loss of 4 cents.
14-hour Data Added to Vyvanse Labeling
Regulators approved a labeling change for Shire plc's Vyvanse (lisdexamfetamine dimesylate) to include additional data demonstrating that the drug significantly improved attention in adults with attention-deficit/hyperactivity disorder (ADHD) across assessments conducted at two, four, eight, 10, 12 and 14 hours after administration.
The labeling change makes Vyvanse the first and only oral ADHD long-acting stimulant to have efficacy data at 14 hours postdose for adults in its labeling.
Vyvanse was first approved in February 2007 to treat ADHD in children ages 6 to 12, and was approved in April 2008 to treat adults with the condition.