A migraine is a neurological disorder which is often characterized by moderate to severe pain on one side of the head. Attacks in the disease can be very intimidating and vary in range and frequency for different patients.
There is a range of medications available for the disease starting from Acute to Prophylactic treatment therapies. Majority of patients rely on these medications to relieve themselves of the throbbing pain experienced and to reduce the frequency of occurrence of attacks.
As per the current scenario, the Acute therapies capture the majority share of a Migraine treated patients. There are hundreds of Acute treatment drugs available in the market including the most popular drugs called Triptans which capture the majority share in the Acute treatment space. Also, Generics for most Acute treatment drugs, including Triptans, are available in the market indicating that the Acute therapies market is already saturated and not much revenue potential is remaining in the market for the companies to look at.
However, the expected launch of newer drugs, Ubrogepant by Allergan and Lasmiditan by Eli Lilly, is set to leverage the untapped market opportunity and potential in the Acute Migraine space. These drugs would have novel Mechanism of Actions and would still be available in the oral formulations thereby offering the efficacy in reducing the Acute pain and the convenience of dosing which the patients seek for in Acute therapies.
Ubrogepant is a CGRP receptor antagonist and the product would be marketed by Allergan. The product is researched in the acute treatment of a Migraine and is currently in Phase III of its trial design. Ubrogepant is expected to be approved and launched in the market by the end of 2020.
Multiple Phase III studies are ongoing for Ubrogepant, the results of which are expected towards the mid of 2018. A Phase II trial was conducted in the past for Ubrogepant which tested multiple doses of Ubrogepant on the patients suffering from Migraine attacks. The primary endpoint of research included the percentage of patients reporting pain freedom at 2 hours post-dose, the percentage of patients reporting pain relief 2 hours after the dose, and the number of participants experiencing adverse events. A total of 834 participants were included in the study and they were tested against Placebo. The results of the study were positive and a significant proportion of patients experienced pain relief and pain freedom at the end of 2 hours after the dose. The drug was also well tolerated amongst the participants.
Lasmiditan is a product by Eli Lilly and is a 5-HT1F agonist. The product would be available for the treatment of Acute Migraine headaches and is currently in the Phase III stage of its trial design. The product is expected to get approved and launched in the market by the end of 2019.
There have been multiple Phase II trials conducted in the past for Lasmiditan. All the Phase II trials for the product yielded positive results for Lasmiditan and significant improvements in the Headache severity were observed in the patients 2 hours after the dose of the drug.
There have been 3 Phase III trials undergoing for Lasmiditan. The first Phase III trial by the name of SAMURAI was conducted in the patients. The trial recruited over 2200 Migraine patients and showed encouraging results to move into the other Phase III trials for the product.
Another Phase III trial by the name of SPARTAN study was conducted and over 3000 patients participated in the trial. The trial was completed in 2017 and a significant proportion of patients participating in the trial reported pain free from a headache and reduced severity of a headache 2 hours after the dose.
Another Phase III trial for Lasmiditan by the name GLADIATOR is underway. The study has recruited around 2580 participants and the study would primarily test the safety of the drug Lasmiditan on the patients. The trial is expected to be completed in 2018.
Assessment of Newer Drugs:
The newer drugs, Ubrogepant and Lasmiditan, have shown superior efficacy in the Acute Migraine patients in the clinical trials. During the clinical trials, the drugs have been effective in reducing the severity of pain in the patients suffering from the attacks and the drugs has also been effective in completely removing the pain in a significant percentage of patients 2 hours after the dose.
Also, the drugs have not shown any major side effects or adverse events during their clinical trials. The products only displayed minor short-term effects and the long-term safety profile of the drug would, however, need to be monitored over a longer period of time after the launch in the market. The products offer a safety advantage over the existing Triptans because the products are free from the CardioVascular side effects which have been a long-standing issue associated with Triptans.
In conclusion, the drugs due to superior efficacy and safety profile as compared to the existing molecules are sure to gain market share in Acute Treatment space and physicians, as well as care providers, are surely looking forward to the launch of these drugs in the market. With the launch of Anti-CGRP molecules in preventive treatment space and launch of innovative Acute treatment drugs, the Migraine market is sure to expand exponentially in the times to come.