Oggg

ASA Member
May 2, 2011
962
21
Status
A new article talks about neoSTX + bupiv infiltration lasted 50h compared to bupiv alone lasting 10h. I was still hoping for PCRX to rebound after it eventually gets the PNB indication, but a new player in the extended LA market would kill PCRX. Anyone know anything about neoSTX?
 

polar403

ASA Member
10+ Year Member
Jan 18, 2007
103
26
Status
Attending Physician
Sounds very promising, but it's nowhere near use in clinical practice any time soon.
 

BLADEMDA

ASA Member
10+ Year Member
Apr 22, 2007
17,397
3,603
Southeast
Status
Attending Physician
A3052
October 13, 2014
3:00 PM - 4:30 PM
Room Room 231-232
Prolonged Local Anesthesia With Neosaxitoxin in Combination With 0.2% Bupivacaine Versus Bupivacaine Alone: A Randomized, Controlled, Double-Blind, Dose Escalation Trial
Laura Cornelissen, Ph.D., Carolina Donado, M.D., Joseph Kim, M.A., Kimberly Lobo, M.S., M.P.H., Mary Ellen McCann, M.D., M.P.H., Karen R. Boretsky, M.D., Joseph Cravero, M.D., Charles B. Berde, M.D., Ph.D.
Boston Children's Hospital/Harvard Medical School, Boston, Massachusetts, United States
Background and Aim: Neosaxitoxin (NeoSTX) is a site 1 sodium channel blocker that has produced prolonged local anesthesia and/or postoperative analgesia, either alone or in combinations with bupivacaine and/or epinephrine in animals1 and preliminary human studies 2. Under an FDA-approved investigator-initiated IND, we studied safety (reported in a separate abstract for ASA2014) and efficacy (current abstract) with NeoSTX (alone) and in combination with 0.2% bupivacaine (BUPI), compared to 0.2% bupivacaine (alone) and placebo. An add-on exploratory study (separate abstract ASA2014) evaluated additional effects of epinephrine (EPI) combined with NeoSTX-bupivacaine.

Methods: After IRB approval and registration at ClinicalTrials.gov (NCT01786655), we performed a double-blind, randomized controlled trial involving healthy male volunteers aged 18-35 years. Subjects were randomized to receive one of 3 injections in the calf (10ml SC): (1) NeoSTX + BUPI (2) NeoSTX alone, or (3) saline placebo. All subjects received 0.2% bupivacaine (BUPI control) in the contralateral calf. The dose range of NeoSTX was 5mcg - 40mcg escalated in a step-wise fashion. Allocation was randomized by a block design. For each dose, one subject received saline placebo, and the remaining subjects were equally divided between NeoSTX+BUPI or NeoSTX alone. Mechanical touch detection (MDT), pain threshold (MPT), and cool temperature detection threshold (CDT) were recorded at baseline, 5min, 30min, 1hr, 2hr, 4hr, 6hr, 12hr, 24hr and then daily for the first 7 days post-injection or until cutaneous sensitivity returned to baseline.

Outcome measures included (1) duration of block and (2) density of block at 12hr and 24hr for each parameter. Complete block was defined as the threshold greater than 4 standard deviations (SD) from the baseline mean. Partial block was defined as the threshold between 2-4 SD from the baseline mean. All bupivacaine data were pooled (n=66). Data reported as median (IQR), ANOVAS with Dunnett´s correction, and Fisher-exact test were used, significance was determined at p<0.05.

Results: 66 subjects completed the study. At all NeoSTX doses, NeoSTX+BUPI provided more prolonged block and more intense block at 12 and 24 hours compared to NeoSTX alone or BUPI alone. For MPT, the duration of complete block for BUPI was 5.0 hrs (IQR 9.7) as compared to NeoSTX+BUPI (18.0 hrs, IQR 23.9; p<0.05); NeoSTX alone (0.5 hrs, IQR 0.4; p<0.05). For MDT, the duration of complete block for BUPI was 7.5 hrs (IQR 12.2) as compared to NeoSTX+BUPI (30.9 hrs, IQR 21.3; p0.1). We were unable to find dose-dependent differences for complete block duration within NeoSTX+BUPI, or within NeoSTX dose cohorts (5-40mcg) in any parameter. Block density at 12 hrs post-injection showed a higher percentage of subjects treated with NeoSTX+BUPI remained completely blocked compared to BUPI (MPT, p<0.001; MDT, p<0.001; CDT, p=0.08; Fisher’s test); Fig 1A. This was also seen at 24hr post injection (MPT, p<0.001; MDT, p<0.001; CDT, p=0.05; Fisher’s test); Fig 1B.

Conclusion: Our data indicate that 5-40mcg NeoSTX given in combination with BUPI is more effective in producing blockade than BUPI alone as measured by mechanical pain detection and mechanical touch detection.

1. Kohane D. et al. RAPM (1):52-9,2000

2. Rodriguez-Navarro A. et al. RAPM. 36(2):103-9, 2011
 

Ignatius J

7+ Year Member
Jan 13, 2010
1,665
464
Status
Attending Physician
Durect (drrx) has a liposomal bupivicaine in the works too (Posidur).
Worth keeping an eye on.
 
OP
Oggg

Oggg

ASA Member
May 2, 2011
962
21
Status
CUPERTINO, Calif., June 23, 2015 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced that, based on feedback from the FDA, it plans to conduct a new POSIDUR (SABER-Bupivacaine) Phase 3 clinical trial consisting of approximately 300 patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. DURECT anticipates beginning the trial in the fall of 2015 and expects that it will take approximately one year to complete enrollment.

"With the FDA's guidance in hand, we now have a clear path forward for POSIDUR," stated James E. Brown, President and CEO of DURECT. "We believe that the data from this additional clinical trial will be supportive of the data we have seen in our other pivotal trials in hernia repair and shoulder surgery, and that these three pivotal trials will support a robust NDA resubmission, for which there would be a 6 month review per PDUFA guidelines. We have previous clinical trial experience with laparoscopic cholecystectomy, which is one of the most common general surgeries performed in the U.S. each year. We believe this is an excellent surgical model and that our overall clinical program for POSIDUR will support a broad label."
 
OP
Oggg

Oggg

ASA Member
May 2, 2011
962
21
Status
1 year to collect 300 lap chole patients? Showing only 25% improvement over bupiv alone? Not impressive. Does neoSTX belong to a public company?
 

Ignatius J

7+ Year Member
Jan 13, 2010
1,665
464
Status
Attending Physician
1 year to collect 300 lap chole patients? Showing only 25% improvement over bupiv alone? Not impressive. Does neoSTX belong to a public company?
Not sure about the study. Here you go, results seem very positive:

http://www.fdanews.com/articles/95967-durect-reports-positive-results-from-posidur-phase-iib-hernia-trial

I'll also edit and add that those results are about on par with Exparel. Plus Drrx has other pipeline drugs and isn't a one-horse company.

Just my two cents.

In full disclosure, I own a lot of Durect stock.
 
Last edited:

dhb

Member
Lifetime Donor
10+ Year Member
Jul 12, 2006
3,914
1,130
Status
Attending Physician
In full disclosure, I own a lot of Durect stock.
"Fifty-three percent of the study patients in the Posidur 5-mL group took supplemental opioid analgesic medications versus 72 percent of the placebo patients."

I would think about realocating; i wouldn't call this very positive.
 

BLADEMDA

ASA Member
10+ Year Member
Apr 22, 2007
17,397
3,603
Southeast
Status
Attending Physician
Not sure about the study. Here you go, results seem very positive:

http://www.fdanews.com/articles/95967-durect-reports-positive-results-from-posidur-phase-iib-hernia-trial

I'll also edit and add that those results are about on par with Exparel. Plus Drrx has other pipeline drugs and isn't a one-horse company.

Just my two cents.

In full disclosure, I own a lot of Durect stock.

At less than $2.00 per share (recent pullbacks were in that range) DRRX is worth the risk.
 

G0S2

SDN Angel
10+ Year Member
15+ Year Member
Oct 11, 2003
1,253
43
44
TX
Visit site
Status
Resident [Any Field]

Ignatius J

7+ Year Member
Jan 13, 2010
1,665
464
Status
Attending Physician
"Fifty-three percent of the study patients in the Posidur 5-mL group took supplemental opioid analgesic medications versus 72 percent of the placebo patients."

I would think about realocating; i wouldn't call this very positive.
I've had about 100% ROI in a year. I think their data looks good. It's nothing crazy. It's liposomal bupivicaine. Just trying to get it to market along with several other formulations.
 

Mman

Senior Member
10+ Year Member
Mar 22, 2005
4,935
2,690
Status
Attending Physician
At less than $2.00 per share (recent pullbacks were in that range) DRRX is worth the risk.
maybe. not exactly profitable right now. They've been pulling in a consistent $4.50 or so in revenue per quarter (per share) for 5+ quarters. They've also been losing a consistent $0.05 per share or so after all the money they spend to make that revenue.
 

Ignatius J

7+ Year Member
Jan 13, 2010
1,665
464
Status
Attending Physician
maybe. not exactly profitable right now. They've been pulling in a consistent $4.50 or so in revenue per quarter (per share) for 5+ quarters. They've also been losing a consistent $0.05 per share or so after all the money they spend to make that revenue.
I don't think you look at small cap pharm companies that way. They have money pits in R&D costs and can explode in revenue once the FDA gives them a nod. That's the upside. Much downside as well.

This is all about taking a risk now hoping some of their drugs and formulations get to market. Maybe they do. Maybe they don't. But as Blade said, it's cheap enough to warrant the risk, IMO. Good candidate for a buyout as well. We shall see.

Edit: One last thing is that they have partnered with Hospira to market it, so pending approval, I don't think it will have any trouble finding it's way into ORs.
 
Last edited:

Mman

Senior Member
10+ Year Member
Mar 22, 2005
4,935
2,690
Status
Attending Physician
I don't think you look at small cap pharm companies that way. They have money pits in R&D costs and can explode in revenue once the FDA gives them a nod. That's the upside. Much downside as well.

This is all about taking a risk now hoping some of their drugs and formulations get to market. Maybe they do. Maybe they don't. But as Blade said, it's cheap enough to warrant the risk, IMO. Good candidate for a buyout as well. We shall see.

Edit: One last thing is that they have partnered with Hospira to market it, so pending approval, I don't think it will have any trouble finding it's way into ORs.
That's actually the way you should look at all stocks. And when you talk about how "cheap" a stock is, the actual cost of a share has nothing to do with it, it's the market cap that measures it. Share price is as much a function of number of shares outstanding as it is value of the business. Apple could sell for $1 a share if they printed enough shares, but that wouldn't make the stock any cheaper.

I'm well aware that a small cap pharma company is spending on R&D and hoping to hit a HR. They might, they might not. The question when speculating is that you have to plot out the odds of them hitting that HR, what kinds of actual sales numbers that will result in, and what percent of those sales gets turned into profit.
 

Ignatius J

7+ Year Member
Jan 13, 2010
1,665
464
Status
Attending Physician
That's actually the way you should look at all stocks. And when you talk about how "cheap" a stock is, the actual cost of a share has nothing to do with it, it's the market cap that measures it. Share price is as much a function of number of shares outstanding as it is value of the business. Apple could sell for $1 a share if they printed enough shares, but that wouldn't make the stock any cheaper.

I'm well aware that a small cap pharma company is spending on R&D and hoping to hit a HR. They might, they might not. The question when speculating is that you have to plot out the odds of them hitting that HR, what kinds of actual sales numbers that will result in, and what percent of those sales gets turned into profit.
Not sure what you're talking about. Durect has a market cap of 300 million. It's a small cap stock. Of course PEG, P/E, P/B, etc. have to do with "cheapness", something investors have subjectively argued about since the beginning of time. You're missing the point.

Your second point has nothing to do with your previous point on them losing money in past quarters. The point is of course they are losing money as their big products aren't even up for sale yet. That's what happens with a lot of small caps. You're betting on the future, not the past or even present.
 

Mman

Senior Member
10+ Year Member
Mar 22, 2005
4,935
2,690
Status
Attending Physician
Not sure what you're talking about. Durect has a market cap of 300 million. It's a small cap stock. Of course PEG, P/E, P/B, etc. have to do with "cheapness", something investors have subjectively argued about since the beginning of time. You're missing the point.

Your second point has nothing to do with your previous point on them losing money in past quarters. The point is of course they are losing money as their big products aren't even up for sale yet. That's what happens with a lot of small caps. You're betting on the future, not the past or even present.
Blade said the stock was cheap because it was $2 a share. My point is that the price of a share is not a measure of how "cheap" a stock is. Market cap is a much better measure. And my point about them losing money in previous quarters is very relevant. Of course with this stock if you buy it you are betting on the future. But you can't even begin to make an educated guess about the future without understanding the past and the present. You need to understand how much (per share) they spend on R&D, how much the spend on marketing, how much they spend on producing the product, how much revenue they generate, how much profit they get from a sale, etc. It's all relevant. Just looking at a company and saying they have a potentially valuable drug and the stock is $2 therefore I should buy it isn't sufficient analysis. You need to figure out the exact numbers to even begin to guess whether a stock is a reasonable vehicle for investing.

If you don't, you are just gambling. And that's OK if that's what you want, but far more sophisticated analysis is necessary to determine if you are making an investment. And please let the record show I have not said anything good or bad about this particular company as an investment idea. I haven't read enough of their annual/quarterly statements and analyzed enough of their balance sheets and cash flows to make that determination for myself. If you have and found it sufficient, good for you, although I'd still hope you wouldn't have a significant percentage of retirement savings in such a tiny stock.
 

Ignatius J

7+ Year Member
Jan 13, 2010
1,665
464
Status
Attending Physician
Blade said the stock was cheap because it was $2 a share. My point is that the price of a share is not a measure of how "cheap" a stock is. Market cap is a much better measure. And my point about them losing money in previous quarters is very relevant. Of course with this stock if you buy it you are betting on the future. But you can't even begin to make an educated guess about the future without understanding the past and the present. You need to understand how much (per share) they spend on R&D, how much the spend on marketing, how much they spend on producing the product, how much revenue they generate, how much profit they get from a sale, etc. It's all relevant. Just looking at a company and saying they have a potentially valuable drug and the stock is $2 therefore I should buy it isn't sufficient analysis. You need to figure out the exact numbers to even begin to guess whether a stock is a reasonable vehicle for investing.

If you don't, you are just gambling. And that's OK if that's what you want, but far more sophisticated analysis is necessary to determine if you are making an investment. And please let the record show I have not said anything good or bad about this particular company as an investment idea. I haven't read enough of their annual/quarterly statements and analyzed enough of their balance sheets and cash flows to make that determination for myself. If you have and found it sufficient, good for you, although I'd still hope you wouldn't have a significant percentage of retirement savings in such a tiny stock.
There is ZERO consensus on identifying if a stock is "cheap". If you do figure out a definitive way to find if a stock is a cheap bargain, let me know. We'll be rich.

Blade was using it in the context of risk/reward. Relative to long-term potential, it is cheap right now. It's subjective.

Your past earnings remarks are off the mark. My point is no small cap pharm company without a good drug to market is going to be profitable. So pointing that out means little. It's stating the obvious.
 

BLADEMDA

ASA Member
10+ Year Member
Apr 22, 2007
17,397
3,603
Southeast
Status
Attending Physician
There is ZERO consensus on identifying if a stock is "cheap". If you do figure out a definitive way to find if a stock is a cheap bargain, let me know. We'll be rich.

Blade was using it in the context of risk/reward. Relative to long-term potential, it is cheap right now. It's subjective.

Your past earnings remarks are off the mark. My point is no small cap pharm company without a good drug to market is going to be profitable. So pointing that out means little. It's stating the obvious.
We agree here. At $2.00 I'd take a "speculative bet" that the company will survive and the stock goes to $20 maybe even $30 per share. If it hits $2.00 again I'm in for 5,000 shares initially.

http://finance.yahoo.com/news/drrx-second-quarter-2015-financials-191500480.html
 

Mman

Senior Member
10+ Year Member
Mar 22, 2005
4,935
2,690
Status
Attending Physician
There is ZERO consensus on identifying if a stock is "cheap". If you do figure out a definitive way to find if a stock is a cheap bargain, let me know. We'll be rich.

Blade was using it in the context of risk/reward. Relative to long-term potential, it is cheap right now. It's subjective.

Your past earnings remarks are off the mark. My point is no small cap pharm company without a good drug to market is going to be profitable. So pointing that out means little. It's stating the obvious.

There are lots of ways to determine if a stock is cheap or expensive. Share price is not one of those. That's my point. My other related point is that to make those determinations you should have a good understanding of the structure of the business and the finances of the business. You need to read the balance sheets and other financial statements. The most promising drug in the world can still be a poor stock purchase because of structural problems in the company that will prevent it from being profitable even if their drug takes off.

I have no opinion one way or the other on this company as I haven't bothered to read the necessary statements.
 
Last edited: