Did Renckiser Panic and Sue BDSI simply because BDSI's Bunavil tastes better than Renckiser's Suboxone?
Adverse events were manageable in the Bunavail arm of the study, with headaches serving as the most common side effect, occurring in 5.2% of patients, followed by fatigue and lethargy, reported in 2.4% of patients. Taste (an important factor in sublingual/muccal delivery) was also favorable. In its own clinical studies, almost 93% of Renckiser's Suboxone patients reported unpleasant tastes, versus 8% for Bunavail in the BNX-201 trial, due to its citrus flavoring. Given that Bunavail is based on a well-documented therapeutic agent and features a favorable side effect profile, we believe the product stands a good chance of securing approval.
But what of the commercial opportunity? Can BioDelivery take share from Suboxone? And more importantly, won't the presence of generics negate the market opportunity?
Suboxone generated sales of more than $1.5 billion in 2012, and currently holds virtually the entire market; Zubsolv [from Orexo (GM:ORXOF)] was approved by the FDA in July 2013 but to date has had little impact on the market. Generic Subaxone tablet sales began in March 2013 [Actavis (ACT) is attempting to launch generic Suboxone film strips, but has been sued by Reckitt Benckiser], but again have not dented sales of film strips.
Buy buy buy BDSI. Bye-bye.
I personally think they sued them because once Bunavail goes on the market, I believe it will take 90% of Reckitts Suboxone revenue. As I stated in the past I currently take Suboxone (half a 2mg/.5mg film) and have been following this stock for over 6 years. The reason why I think Reckitt is so worried is unlike being a generic just like every other drug has, Bunavail is healthier then Suboxone. I don't know what Bunvail taste like but the taste of suboxone isn't really that bad. People who complain about it in my mind are people looking for excuses not to take it. If Suboxone literally tasted like rotten milk, I would still take it not to be addicted to opiates.
Apparently half of whatever dosage you take with Suboxone only half gets absorbed by the receptors and the other half gets absorbed into the endocrine system. I'm sure that is the reason for some of the side effects I experienced with Suboxoxe such as try mouth, water retention and head aches as well.
With Bunavail the Dr will only need to prescribe half the dosage that would be needed with Suboxone because 100% of the medication goes to the receptors. So if I was a Dr. once Bunvail is available, I'd rather prescribe one 12mg/3mg film instead of 24mg/6mg of Subxone which is what I started with years ago. So its that much less medication being prescribed and less harmful to a persons body. With those reason I can see why Reckitt is so worried and throwing lawsuit after lawsuit at BDSI!