![](https://investorshub.advfn.com/uicon/386739.png?cb=1666470865)
Thursday, April 23, 2015 1:13:01 PM
Just to remind everybody, the Probuphine study is a randomized, double-blind, double-dummy designed that enrolled 178 patients into two parallel treatment arms across 20 clinical centers. Study participants are clinically stable patients who receive maintenance treatment with an improved sublingual formulation containing Buprenorphine at a daily dose of 8 milligrams or less.
Patients have been randomized to receive either four Probuphine implants or to continue their daily sublingual Buprenorphine therapy.
Now to enable the double blind design, those receiving Probuphine implants are required to take daily placebo sublingual pills, while those continuing on their stable dose of sublingual Buprenorphine pills are required to be treated with four placebo implants. The patients are expected to be treated for six months and the primary analysis will be a non-inferiority comparison of responders in the two treatment arms.
Responder status will be based on an FDA agreed upon clinical algorithm, and as based on urine testing for opioid use, together with patient self-reported opioid use. We believe this study design is robust and will provide a well-controlled evaluation of Probuphine compared with the current standard of care in these stable maintenance patients.
Now off note, all participants are receiving active treatment during the study. We continue to support Braeburn in all study related efforts and are encouraged by the progress to date.
As previously mentioned, we expect study results in late second quarter of this year and we're looking forward to assisting Braeburn in the re-submission of the NDA in the second half of this year with the potential for product approval in the first half of 2016.
Take Care and God Bless....God Bless Us All.
TRUTH
I've never claimed to have all the answers but feel i'm beginning to corner the market in questions worthy of them.
Recent TTNP News
- Form 8-K - Current report • Edgar (US Regulatory) • 01/25/2024 09:33:11 PM
- Titan Pharmaceuticals Fully Compliant With NASDAQ Listing Criteria • GlobeNewswire Inc. • 01/25/2024 09:29:23 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/18/2024 09:59:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2024 10:13:45 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/28/2023 09:30:20 PM
- Titan Pharmaceuticals Announces Reverse Stock Split and Ratio • GlobeNewswire Inc. • 12/28/2023 09:15:00 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/28/2023 09:47:46 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 11/17/2023 09:03:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/15/2023 09:05:15 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/26/2023 08:33:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/26/2023 08:31:25 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/26/2023 08:29:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/26/2023 08:25:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/26/2023 08:23:37 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 10/24/2023 09:26:34 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 10/23/2023 07:07:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/16/2023 09:08:35 PM
- Titan Pharmaceuticals Announces Appointment of Dato' Seow Gim Shen and Brynner Chaim to the Company's Board of Directors • GlobeNewswire Inc. • 10/16/2023 08:37:23 PM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 10/04/2023 09:30:18 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 09/19/2023 08:41:40 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/18/2023 08:45:22 PM
- Titan Pharmaceuticals Announces $9.5 Million Private Placement of Convertible Preferred Stock • GlobeNewswire Inc. • 09/18/2023 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/08/2023 09:30:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/30/2023 08:28:25 PM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM
VAYK Exited Caribbean Investments for $320,000 Profit • VAYK • Jun 27, 2024 9:00 AM