Prescription pain medication and illicit opiate based drugs are becoming easier than ever before to obtain, in fact about 9% of the population is believed to misuse opiates at some point over the course of their lifetime. With this availability and extremely high potential for abuse comes the potential for opioid dependence.
If a person is opioid dependent for a long period of time, and attempts to abruptly discontinue use, they can experience opioid withdrawal, which is fraught with physical dangers that range from nausea and vomiting to strokes, seizure, and even death. Serious psychological symptoms ranging from depression to suicide attempts also occur, but the most common psychological danger is relapsing back into drug use.
The opioid treatment market is currently dominated by Suboxone, a combination of buprenorphine and naloxone, indicated for the maintenance treatment of opioid dependence. While effective, Suboxone comes in a tablet form that has a significant abuse potential as all conventional tablet forms have been subjected to. These tablets also have a habit of being found by small children in households leading to accidental ingestion or worse.
Three Biopharmas, Titan Pharmaceuticals (OTC:TTNP), BioDelivery Sciences (BDSI), and Durect (DRRX) are taking a unique approach at this opioid addiction market worth an estimated $1.2 Billion, and growing each day. In this article I will give a quick breakdown of each company's key products, history, and potential for success.
Titan produces an intradermal delayed-release delivery system, similar to those seen in birth control implants. These rod shaped implants are placed under the skin and deliver a consistent amount of Probuphine over several months to achieve a consistent delivery, and low possibility of tampering to promote a successful recovery.
After receiving priority review by the FDA, on March 21, 2013, The U.S. FDA Psychopharmacologic Drugs Advisory Committee voted to recommend approval, with only a few noted issues in regards to the relatively low tested dosage and need for an extra sublingual booster, and a redesigned Risk Evaluation and Mitigation Strategies (REMS).
The first issue of the relatively low dosages was a large topic of discussion, as several of the panel members felt that the implant dosage tested during the clinical trial was on the lower side of what the patients may actually need for treatment, as evidenced by the patients usage of supplementary sublingual tablets that were offered. It is important to note that throughout the clinical trial this supplementary usage declined steadily among subjects as they began to attune to the implants and break their oral fixation habits that lingered from abuse.
The second issue of the Risk Evaluation and Mitigation Strategies was discussed fully during the advisory board, and Titan appears to be very receptive to the proposed changes made by the FDA. This temporary delay in revision will most certainly be overcome and not hinder the final approval of the drug.
BioDelivery Sciences is creating a low abuse alternative to Suboxone in the form of its BioErodible MucoAdhesive (BEMA) buprenorphine delivery system known as Bunavail. Consisting of a small piece of bioerodible polymer film that fixes to the inside of the cheek and delivers the drug across the mucous membrane, BEMA has proven to be an effective delivery method with the advantage of being difficult to abuse by smoking, snorting, or injecting. BioDelivery Sciences expects the submission for NDA to happen in mid-2013. If approved, it will be the first major competitor to go up against Suboxone.
It's also important to note that BioDelivery Sciences has a phase II clinical program underway for a BEMA version of an opioid medication towards the management of both acute and chronic pain conditions. Endo Pharmaceuticals has already seen such promise in it that it has closed a deal of $180 million for exclusive rights to the product.
What is a better way to treat opioid addiction and abuse than by preventing it in the first place? There is none, says Durrect Corporation, who are currently producing a form of the popular oxycodone pain reliever that contains properties designed to resist common methods of prescription drug misuse and abuse.
Their abuse-deterring drug, Remoxy, is being developed in a partnerhip with Pain Therapeutic (PTIE) and Pfizer (PFE), and is resistant to abuse attempts such as snorting, smoking, injecting, and dissolving. If approved, Remoxy has the potential to take a large chunk out of the $3.8 billion dollar oxycodone market.
Remoxy has failed to gain approval twice, in 2008 and 2011 after the FDA raised concerns relating to the bioavailability and pharmacokinetics of the compound. To attempt to overcome this issue, Pfizer has run two studies in 2012 of which the data should be available very soon. Trading at a mere $1.30 a share, there is significant room for this stock to run on good news, and if it were to be hindered, Durrect has six other prime pipeline candidates to fall back on, limiting the potential loss.
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In my opinion, Titan is a great buying opportunity after it took an unexpected drop from $2.04 to $1.19 a share after passing the panel review. It has already regained most of it's ground to $1.70 a share, and I expect to see a significant run up from now till it's possible approval on April 30th. On the off chance that the approval decision is postponed for 1-3 months due to the need for the REMS plan to be completed, there is still a large potential as I feel it's not if this drug is approved, but when.
I wouldn't take any action on this stock, especially with it trading at $4.28. But watch it closely through the submittance of its NDA. If all goes well, it is important to understand that this will be the first direct competitor to Suboxone and stands to gain a large share of the opiate addiction market from it.
I absolutely love everything about this product, and the partnerships, but the two prior failed submittals to the FDA throws caution to the wind. I would watch carefully for the Pfizer bioavailability and pharmacokinetics studies, and if everything looks like a good buy in, because it will have an excellent chance against the FDA.