With only weeks left for the FDA to decide on Labopharm Inc.'s (DDSS) (DDS.TO) investigational drug DDS-04A, a novel once-daily formulation of antidepressant Trazodone, investors and traders are placing their bets. The decision date is on February 11. This is DDS-04A's second go-around with the FDA.
On July 20, 2009, Labopharm received a complete response letter from the FDA for the new drug application submission of DDS-04A. The FDA in its complete response letter indicated the deficiencies related to the API (active pharmaceutical ingredient) supplier's manufacturing facility. Angelini is the manufacturer of the API for Labopharm's novel Trazodone formulation. However, no efficacy or safety issues were raised.
Angelini submitted an action plan addressing the deficiencies to the FDA on July 24, 2009. The following month, Labopharm submitted its response to the FDA's complete response letter regarding the novel formulation of Trazodone. The regulatory agency, which accepted Labopharm's response, assigned a new action date of February 11, 2010.
Major depression is one of the most prevalent central nervous disorders, affecting more than 120 million people worldwide. The annual sales of antidepressants in the U.S. alone total in excess of $12 billion.
The antidepressants that are currently used are plagued by certain limitations like delayed onset of therapeutic response, insomnia or sleep disturbance, sexual dysfunction and anxiety to name a few. According to the World Health Organization, 40% of patients treated with current antidepressants discontinue treatment within the first 12 weeks due to limitations with existing products and their unwanted side effects.
Trazodone is a SARI (serotonin antagonist reuptake inhibitor) with proven efficacy as an antidepressant. Labopharm's novel formulation of Trazodone is a controlled release formulation designed to optimize the efficacy of Trazodone, and address the major challenges in treating depression.
The novel Trazodone formulation contains Contramid, which is Labopharm's clinically validated proprietary technology that controls the release of active substances from oral medications to optimize drug delivery.
The October 2009 issue of the international journal of neuropsychiatric medicine, CNS Spectrums, has published the potential benefit of Labopharm's novel Trazodone formulation.
According to the author of the article, Stephen Stahl, "Controlled-release Trazodone should theoretically allow adequate dose escalation to administer high doses for antidepressant action while avoiding sedation of the immediate release formulation. As an antidepressant, the new Trazodone formulation should be as effective as SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin norepinephrine reuptake inhibitors), yet as a serotonin antagonist reuptake inhibitor, have a low incidence of anxiety, insomnia and sexual dysfunction."
Labopharm filed its New Drug Application for DDS-04A in September 2008 under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. This section typically applies to reformulations of drugs that are already approved and being marketed, allowing the company to refer to existing efficacy and safety data on Trazodone.
Labopharm's NDA was based on data from five pivotal pharmacokinetic studies and the positive results from its North American phase III placebo controlled clinical trial, which enrolled over 400 patients.
DDS-04A is the rapid-onset formulation of Trazodone that was approved by the FDA in 1982 for the treatment of depression in adults. Trazodone was sold under the brand name Desyrel by Bristol-Myers Squibb Co. (BMY). Following the expiry of the drug's patent, generic version of Trazodone became available and the brand-name version is no longer being manufactured.
According to Labopharm, in the phase III study dubbed 04ACL3-001, the primary endpoint achieved statistical significance providing an improvement from baseline to the end of the study as measured by the Hamilton Rating Scale for Depression (HAMD-17).
Patients treated with DDS-04A experienced rapid onset of action as demonstrated by a clinically significant improvement in HAMD scores within the first two weeks of treatment. In addition, the study demonstrated an improvement in the overall quality of sleep and a favorable adverse event profile, including transient mild to moderate somnolence, no difference from placebo in anxiety, agitation, sexual dysfunction and weight change.
Meanwhile, preparations for the commercialization of the drug in the U.S. are underway and if approved, the company intends to launch the drug in the first half of 2010. The company is also in discussions for partnership.
Labopharm has also sought approval of the novel formulation of Trazodone in Canada and its new drug submission is under regulatory review with Health Canada. The Canadian regulatory agency is expected to decide on the drug on August 4, 2010.
Ryzolt, a once-daily formulation of the analgesic Tramadol is the company's first U.S. FDA-approved drug. Ryzolt, approved by the FDA in December 2008 for the management of moderate to moderately severe chronic pain in adults, was launched in the U.S. last May by Labopharm's U.S. marketing partner, Purdue Pharma Products L.P.
Under its licensing and distribution agreement with Purdue Pharma for Ryzolt in the United States, Labopharm is entitled to royalty payments of 20% of Purdue's net sales of the product.
Labopharm's once-daily tramadol product is already marketed in Europe, Canada, South Korea, Australia, and a number of countries. The company markets its product primarily through licensing and distribution arrangements with local pharmaceutical companies.
The company has completed phase III trials evaluating an investigational drug, which is a twice-daily formulation that combines the analgesics Tramadol and Acetaminophen. According to the company, the results of the trial are insufficient to support the acceptance of a New Drug Application by the FDA in the United States. However, the company believes that the trial results may be accepted for the evaluation of analgesics in Europe, Canada and other jurisdictions.
Last month, Labopharm initiated the regulatory approval process for its twice-daily tramadol-acetaminophen formulation in Europe under the DCP (Decentralized Procedure). The DCP provides an efficient mechanism that allows a company to simultaneously pursue regulatory approval for a medicinal product in multiple jurisdictions in Europe. The DCP is expected to take approximately one year to complete after which the national Marketing Authorizations will be provided.
In order to better support the full commercial potential of its products, pipeline and technologies, the company embarked on streamlining its operations last November, eliminating 35 positions. According to Labopharm, the reduction in workforce is expected to result in annual cost savings of about $3 million.
For the third-quarter ended September 30, 2009, the company's net loss widened to C$6.9 million or C$0.12 per share from C$6.02 million or C$0.11 per share in the year-ago quarter.
The company generates revenue from product sales, research and development collaborations, and licensing arrangements.
Quarterly revenue declined to C$6.62 million from C$9.44 million in the comparable year-ago quarter. While product sales of the company's once-daily Tramadol product rose an impressive 34% to C$5.19 million in the recent third-quarter, compared to the year-ago third-quarter, licensing revenue plunged 79% to C$1.19 million.
The company made its trading debut on the Nasdaq only on April 28 2006, with its IPO priced at $8 per share. However, the company's shares have been trading on the Toronto Stock Exchange since 1996.
In the last twelve months, the stock has been trading in the range of $0.76-$2.95 on the Nasdaq and in the range of C$0.43- C$3.40 on the Toronto Stock Exchange.
The upcoming FDA decision on DDS-04A is a significant catalyst for Labopharm's stock. Will the drug pass muster with the FDA this time? Stay tuned...
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.