We've been granted Fast Track designation. We've completed two phase III trials with statistical significance, and we expect to launch in 2025. We also have two marketed products for migraine headache: Zembrace and Tosymra. We are already a fully integrated company with commercial products. We have a number of strategic partnerships with world-class institutions and a very rich pipeline. Some of the pipeline I'll take you through today. Finally, we have a lot of distinctive internal capabilities. We are selling prescription drugs already, Zembrace and Tosymra, and we have R&D going on at facilities that Tonix owns and operates. Here's our pipeline. You can see the most advanced in development at the top is TNX-102 SL , and that is the lead indication is fibromyalgia, and we expect a decision on FDA market authorization August 15 of this year.
This is a completely homegrown product, so we've taken it from discovery all the way to now where the new drug application is submitted. We're also developing that program for acute stress disorder, and that study is expected to start relatively soon. We have an antidote for cocaine intoxication called TNX-1300 . We have an antibody to CD40 ligand called TNX-1500 , and we've recently reported top line in that study, and I'll take you through some of those data. TNX-4200 is the subject of a contract with the Department of Defense for up to $34 million. We announced that in July of last year, and we have a vaccine in development for smallpox and mpox called TNX-801 . Our Flash financials, as of January 31, we had 5.6 million shares.
In the fiscal year of 2024, we're at $98.8 million, and we spent last year $60.9 million, which was significantly less than the year before. We recently repaid a $9 million loan that was a mortgage on our two research facilities, and we guide that we have cash to get us into first quarter of 2026. I'm going to now focus on our lead program, TNX-102 SL, for treatment of fibromyalgia. Fibromyalgia is a chronic pain disorder. It's characterized by pain all over the body, trouble sleeping, and fatigue. It's known as many things when it's known as a chronic overlapping pain condition and also as a nociplastic pain syndrome. Nociplastic pain is now recognized as the third type of pain. Nociceptive pain on the left is traditional pain. Neuropathic pain on the right relates to damage to nerves.
Here are some examples of conditions that typify these three different types of pain. You can see that for nociplastic pain, which is the most newly recognized type of pain, fibromyalgia is at the top of the list. Other things are chronic fatigue syndrome, long COVID, migraine, post-concussive syndrome, irritable bowel syndrome, endometriosis, and low back pain. Nociplastic pain is always pathologic, same thing with neuropathic, but nociceptive pain is pain that actually serves a function and warns the person about real or threatened body injury. For fibromyalgia, there is a vicious circle between worse pain and worse sleep. Our drug actually targets the bad sleep that is particular to fibromyalgia. You can call this a vicious circle.
You can also call it a vortex because when someone has fibromyalgia, in addition to this bad pain and worse sleep, they also get fatigue and they get brain fog. Our drug works by targeting the bad sleep of fibromyalgia, but it's important how you target the bad sleep. It's been shown that drugs like Ambien do not work, so we had to find a different way. Going back to fibromyalgia, it's a common problem. More than 10 million American adults are affected, primarily women. There are three FDA-approved drugs, but patients are dissatisfied. There are about 3 million people who are diagnosed and treated, and there has not been a new drug since 2009. Our offering is called TNX 102SL. It is a sublingual tablet version of cyclobenzaprine, and it goes into the brain and interacts with four key receptors that facilitate restorative sleep.
The fact that it's a sublingual tablet is important because relative to oral cyclobenzaprine, we have lower daytime exposure, we avoid first-pass metabolism, and have reduced pharmacologic interference from the major metabolite. I'll describe later how it compares to some of the other drugs in the market. TNX 102SL, this is our regulatory history. The most important thing is we filed the new drug application in October. We were assigned a PDUFA date in December, and we expect the marketing authorization decision on August 15th. Here's a summary of our clinical program. We did three phase III studies at the 5.6 milligram dose. The first one and the third one were statistically significant results. The second study missed its primary endpoint, and we believe that that's because that study was conducted during the peak time of COVID in the United States, and we think that COVID confounded it.
In terms of tolerability, we had 80% of patients roughly completed at the similar level on drug and placebo. There were no new safety signals. The systemic adverse events were low, but there were somnolence and headache, somnolence at 3% and headache at 3%, each of them versus placebo rates at 1.3% and 1.8%. The most common side effect is an administration site reaction where people get transient numbness under the tongue where the tablet was placed. We did not have many of the side effects that are associated with the approved fibromyalgia drugs. For example, we did not have weight gain, insomnia, or a decrease in sexual function. As a matter of fact, we had an improvement in sexual function in the last study. Cyclobenzaprine as an oral drug, oral swallow drug, it's been around since 1977. It was marketed as Flexeril by Merck.
Over the years, there have been a number of people who have studied it in fibromyalgia between 1988 and 2004. None of those studies showed a durable benefit. They all showed a short-term benefit that went away. We are looking for a durable benefit because fibromyalgia is a chronic pain condition. At the right, you have an image of cyclobenzaprine with the tricyclic nucleus. Tricyclic means three rings and then the tertiary amine tail. Oral cyclobenzaprine is converted in the liver from a tertiary amine in the middle bottom of the slide to a secondary amine. That means that one of the methyl groups is cleaved off. When people take cyclobenzaprine on a daily basis by mouth, you get a situation where there is more of the secondary amine called norcyclobenzaprine than there is cyclobenzaprine in the bloodstream.
We think that this may relate to the fact that oral cyclobenzaprine only gives a transient benefit. Cyclobenzaprine and the metabolite norcyclobenzaprine have different interactions with receptors in the brain. In green are shown the affinities, and in this, a low affinity is good. In green, the low affinities, the high affinities, low KIs for receptors in the brain that relate to sleep quality. In red at the bottom right, it shows that the metabolite has a relatively high binding affinity, which is a low number for the norepinephrine transporter. Drugs that inhibit the norepinephrine transporter are typically associated with sleep issues and alertness or wakefulness. In general, we want to have a drug that has good exposure of cyclobenzaprine, the parent during nighttime, during sleep time, and low amounts of norcyclobenzaprine.
During the day, it would be okay, possibly even beneficial if those flipped. Here you have cyclobenzaprine and norcyclobenzaprine again, where the liver cleaves off a methyl group, making the tertiary amine into a secondary amine. What we've shown with our studies on repeat dosing is that with daily repeat dosing, cyclobenzaprine is high at night and higher than norcyclobenzaprine because we bypass liver metabolism. We think that this is why we get durable benefits with our drug. Going to the fibromyalgia market, these are the three approved drugs: pregabalin, duloxetine, and milnacipran. Pregabalin is a gabapentinoid, and duloxetine and milnacipran are SNRIs. All of the drugs improve pain because fibromyalgia is a chronic pain disorder, but pregabalin has some benefit on sleep but makes fatigue arguably worse. SNRIs do not improve sleep.
They're even associated with insomnia, but they may help with fatigue. You can see the side effects below are many, and tolerability is one of the biggest problems with these drugs. We have done market research, and we found that there's a high unmet need in fibromyalgia. A lot of physicians pointed to the potential activity and tolerability of 102SL as potential advantages. We learned that about 40% said they plan to use it in their practice. This is a somewhat alarming statistic about what fibromyalgia patients get today. This is the prescriptions that they get within 18 months of being diagnosed with fibromyalgia. There are two surprising things. First of all, the drugs that are FDA-approved, which are shown here in green, duloxetine, pregabalin, and milnacipran, these are prescribed not frequently enough.
As a matter of fact, if you look at the opiates that are in red, hydrocodone, oxycodone, and tramadol, the opiates are prescribed more frequently than all three of the FDA-approved products combined. In addition to fibromyalgia, we're looking at other indications. I mentioned at the beginning, we're expecting to soon start dosing a study for acute stress reaction. This is being conducted at the University of North Carolina, and this study is funded by the United States Department of Defense. This is a description of the trial, and why we're motivated to do it. The important thing about it is that we're motivated to see whether patients, people who have just experienced motor vehicle collision, would benefit from a two-week treatment of TNX 102SL to treat acute stress reaction and also to basically, hopefully, prevent the occurrence of PTSD.
Another area that's of interest to us is long COVID. There's significant overlap between fibromyalgia and long COVID. Data that we've presented from claims data suggests that 40% of long COVID patients present with a constellation of symptoms that overlap with fibromyalgia. In June of 2024, the National Academies of Science concluded that fibromyalgia was a diagnosable condition in long COVID. We believe that diagnosing patients with fibromyalgia in long COVID will increase the potential market for TNX 102SL. This program has a lot of patents. At the top, I just focus on issued U.S. patents that relate to our unique formulation. These patents have issued all over the world, but they protect us in the United States until about 2034. They've already been challenged by a big generic company, Sandoz, in Europe. Our patents survived, all of the claims survived the patent challenge.
They've been road tested. Now let me tell you about our marketed products. We market two prescription drugs for migraine: Zembrace and Tosymra. Zembrace is an auto injector, and Tosymra is a nasal spray. Both of them are indicated for the acute treatment of migraine. We're very excited about the characteristics of these drugs, but we're also excited because these drugs have allowed us to set up a commercial operation that will prepare us for the launch of TNX 102SL for fibromyalgia. We have a significant effort in infectious disease. We have a vaccine called TNX 801 in development. In addition to being a vaccine for smallpox and horsepox, it's potentially a platform for other vaccines. For example, we've done some work in COVID-19, but there are other potential vaccines that we can make on this backbone.
Our work on vaccines happens at our R&D center in Frederick, Maryland, which is a sophisticated state-of-the-art facility that includes BSL-3 facilities. We have built a facility to manufacture our vaccine in Dartmouth, Massachusetts. We call it the Advanced Manufacturing Center. This is a very capable facility, but we have notified the market that we have decommissioned the manufacturing suites pending later-stage clinical development of our vaccine program. Our TNX 801 is a minimally replicating vaccine, which is shown here in the middle of this graph. On the left side of the graph is tolerability. We are in a range of vaccines that have very good tolerability, where the other side in orange would be reactogenicity, which is not good.
One of the things that's very interesting about our vaccine is with this great tolerability that we've seen in animals, we maintain good activity in terms of protecting against diseases. The WHO recently declared in August of last year a world public health emergency of international concern. This new Mpox virus called Clade 1 is spreading all over the world, and there have been cases identified in the United States and multiple other countries. We also have a broad-spectrum antiviral program that was funded with a $34 million contract with the United States Department of Defense. We're excited about that program. This is a description of the contract. One of the most recent programs that we've had data on is TNX 1500, which is a monoclonal antibody directed against the CD40 ligand. This has been a program that I've been involved with for about 30 years.
We have engineered the bottom portion, the FC portion of the antibody to improve the tolerability of this product but maintain the efficacy. Here are the top-line results that we recently reported. We give a lot of data here. This will be on our website. I just want to say that we think that this is best in class for anti-CD40 ligand antibodies. Our data suggests that our product can be delivered with monthly dosing. The indications we're pursuing are the prevention of organ transplant rejection and the treatment of autoimmune disease. You can see here allograft rejection. That's human kidneys and a human recipient. That will probably be the first study that we start. We are working on bone marrow transplant and finally autoimmune diseases, which is potentially the biggest market.
In terms of our team, we have a great team of senior managers who have worked together for a number of years. Again, we're a complex business with fully integrated all the way from marketed products to true discovery. Here are our milestones completed and upcoming. The most important milestone, August 15, 2025, is the FDA decision on marketing authorization for TNX 102SL for fibromyalgia. We have a number of other milestones coming up. At the bottom, you'll see to initiate the phase two study at the University of North Carolina for TNX 102SL for the treatment of acute stress disorder. This is funded by the Department of Defense. At the very bottom, we have an ongoing study of TNX 1300 for the treatment of cocaine intoxication. This program is funded by the U.S. NIDA, NIDA, National Institute on Drug Abuse.
These are the end. First of all, thank you very much for your attention. Now I'm going to go to the questions. One question: what's the initial production capacity for the launch of TNX 102SL for fibromyalgia? I can say we have two facilities set up to produce it. We believe that we're in a very good condition to supply the U.S. demand for 102SL on launch. Another question: can you explain the benefit that we got from Fast Track for TNX 102SL? We got Fast Track for TNX 102SL in July of 2024. Drugs can get Fast Track designation early on or late on. By the time we got it awarded, there wasn't that much benefit for us. It did signal that the FDA had seen our presentations from the two pre-NDA meetings.
Based on the information that we provided, decided to award us Fast Track. There was a hope that we might get priority review since we had gotten Fast Track. When we got the NDA acceptance and the day 74 letter, the FDA did give us regular review, which is why we expect a decision on FDA approval in August of 2025. One of the questions: what's the chance TNX 102 will be approved before August? That does happen. It is a possibility, but I can't guide on that. All I can say is we've been very responsive to information requests with FDA. Generally, I'm cautiously optimistic about the progress of the FDA review. One of the questions: can you update us on the development of the broad-spectrum antiviral? Yeah.
The way this contract works is that we do research and then periodically submit invoices to the Department of Defense. The part of that we work with is called DITRA, Defense Threat Reduction Agency. We've publicly stated that we have submitted several invoices for reimbursement. Since this is a $35 million five-year program, you can imagine that several of these invoices are significant amounts of money. Question: expand on TNX 1300. That's the drug in development for cocaine intoxication. There is a phase two study that has been completed and published. That was done in laboratory volunteers where they got different doses of cocaine, and then they were treated with the cocaine antidote. What we showed was we got more than 90% reduction in the amount of cocaine in the bloodstream within two minutes. There's a question about foreign countries and what we're doing.
Right now, we are focused on the United States. The United States is the biggest pharmaceutical market in the world. We do have patents that cover, for example, 102SL in Europe, Asia, a lot of places where we think there are potential markets. We are constantly in discussion with potential partners. I can't update you with anything specific on what's going on with that. I think we're up with just two minutes to go. I'm really grateful to everyone's participation. Thank you for your questions and your interest. Again, I'm Seth Lederman, CEO of Tonix Pharmaceuticals. Stay tuned. We have a lot of news coming up this year, particularly the FDA decision on TNX 102SL for fibromyalgia. Thank you.