- Eli Lilly and Co.'s push into development of new therapies for pain took another step forward last week with the announcement of positive results from a second Phase 3 trial of the drugmaker's migraine drug lasmiditan.
- In the dramatically named SPARTAN study, acute treatment with the highest dose of lasmiditan nearly doubled the percentage of patients who were migraine pain-free two hours after administration compared to those on placebo.
- The results set up a potential filing for approval of lasmiditan by the second half of next year, by which time Lilly may already have secured an OK from the Food and Drug Administration for its preventative migraine treatment galcanezumab.
With lasmiditan moving forward toward a regulatory filing next year, Lilly could have a complementary acute treatment to go along with its CGRP inhibitor galcanezumab.
In clinical studies, galcanezumab showed competitive reductions in the number of monthly migraine days experienced by migraine patients. A filing is planned for later this year in both episodic and chronic types of the debilitating headache condition, keeping Lilly in the running as other drugmakers advance their own CGRP inhibitors.
While Amgen and Novartis look set to be first to market with Aimovig (erenumab), Lilly could own a broader slice of the migraine market if it eventually secures approval for lasmiditan alongside galcanezumab. In a recent call with analysts, director of Lilly BioMedicine Christi Shaw noted having an acute treatment for migraine to offer alongside a preventative therapy could prove compelling to payers down the road.
Lasmiditan's success in SPARTAN also helps to validate Lilly's decision to pay $960 million in January to acquire CoLucid Pharmaceuticals, Inc., which has been bringing the drug forward for the last 12 years. Lilly, interestingly, was the orginal developer of the drug and out-licensed the compound in 2005.
SPARTAN tested three doses of lasmiditan: 50 mg, 100 mg and 200 mg. Across all three doses, a greater percentage of patients treated with the drug were migraine pain-free compared to placebo. Nearly 39% of patients receiving the 200 mg dose, for example, experienced no migraine pain two hours after treatment versus only 21.3% of patients who took the placebo.
The results were consistent with a prior Phase 3 study, known as SAMURAI, that tested 100 mg and 200 mg doses of lasmiditan. In both studies, the primary endpoint focused only on the 200 mg version of the drug.
Migraines are typically treated with a class of drugs known as triptans, which aren't well-tolerated by many patients. Unlike the triptans, lasmiditan works without vasoconstriction activity — an important difference that may mitigate some of the cardiovascular side effects seen with the older drugs.
The most common side effects associated with lasmiditan were dizziness, paresthesia, somnolence, fatigue and nausea. Dizziness, in particular, occurred in between 13% and 16% of patients on the 200 mg dose in the SAMURAI study, although that number decreased following a second dose.
While Lilly has two positive Phase 3 read outs in hand for lasmiditan, it still needs to complete some pharmacology studies before submitting the drug to the FDA. Those are expected to wrap up by the second half of 2018, upon which Lilly expects to file for approval.